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Abramson Cancer CenterNCI CANCERLIT® Search: Chemotherapy for Non-small Cell Lung Cancer - July 2002
National Cancer Institute®
Last Modified: July 1, 2002
- Platinum-based and non-platinum-based chemotherapy in advanced non-small-cell lung cancer: a randomised multicentre trial.
- Chemotherapy for non-small-cell lung cancer.
- Chemotherapy for non-small-cell lung cancer.
- Chemotherapy in advanced nonsmall cell lung cancer: indication, intensity, and duration.
- Individualized chemotherapy for elderly patients with nonsmall cell lung cancer.
- Phase I study of N(1),N(11)-diethylnorspermine in patients with non-small cell lung cancer.
- Cancer medicine hits a target.
- Prognostic factors for patients with small cell lung carcinoma: analysis of a series of 763 patients included in 4 consecutive prospective trials
- The predictive value of neuroendocrine markers and p53 for response to chemotherapy and survival in patients with advanced non-small cell lung
- Phase I dose-escalating study of raltitrexed ('Tomudex') and cisplatin in metastatic non-small cell lung cancer.
- Phase I trial of gemcitabine and carboplatin in metastatic non-small-cell lung cancer: a Groupe Francais de Pneumo-Cancerologie
- Is long term gemcitabine useful in small cell lung cancer?
- Docetaxel followed by gemcitabine in the treatment of advanced non-small cell lung cancer: a phase I study.
- Gemcitabine, ifosfamide and Navelbine (GIN): a platinum-free combination in advanced non-small-cell lung cancer (NSCLC).
- Chemotherapy in patients with advanced non-small cell lung cancer.
- Mitomycin C, vinblastine and carboplatin: effective outpatient chemotherapy for advanced non-small cell carcinoma of the lung (NSCLC).
- [Guideline for chemotherapy of malignant lung cancer]
- Long-term follow-up of patients treated with paclitaxel/carboplatin-based chemotherapy for advanced non-small-cell
- A phase I study of sequential intravenous topotecan and etoposide in lung cancer patients.
- Chemotherapy in small cell lung cancer.
- Locally advanced non-small cell lung cancer.
- Superior sulcus tumors.
- Advanced non-small cell lung cancer.
- Limited stage small cell lung cancer.
- Extensive stage small cell lung cancer.
- Non-small-cell lung cancer progression after first-line chemotherapy.
- [Modern chemotherapy in bronchial carcinoma]
- Phase II study of uracil-tegafur in patients with metastatic pancreatic cancer.
- A rapid and systematic review of the clinical effectiveness and cost-effectiveness of paclitaxel, docetaxel, gemcitabine and vinorelbine
- Is there a preferred combination chemotherapy regimen for metastastic non-small cell lung cancer?
- Small cell lung cancer: current therapy and promising new regimens.
- New treatment approaches for lung cancer and impact on survival.
- A study of the combination of gemcitabine hydrochloride (LY188011) and cisplatin in non-small-cell lung cancer: 3-week schedule.
- Double-blind randomized control trial of the effect of recombinant human erythropoietin on chemotherapy-induced anemia in patients with non-small
- Re: Cisplatin-based therapy for elderly patients with advanced non-small-cell lung cancer: implications of Eastern Cooperative Oncology
- Randomized phase II chemotherapy and radiotherapy trial for patients with locally advanced inoperable non-small-cell lung cancer: long-term
- Twice daily irradiation increases locoregional control in patients with medically inoperable or surgically unresectable stage II-IIIB
- Incorporation of pemetrexed (Alimta) into the treatment of non-small cell lung cancer (thoracic tumors).
- Gemcitabine and pemetrexed (Alimta) in thoracic cancers: present and future perspectives. Introduction and current controversies.
- Early results of a randomized phase III trial of platinum-containing doublets versus a nonplatinum doublet in the treatment of advanced
- Gemcitabine versus gemcitabine/carboplatin in advanced non-small cell lung cancer: preliminary findings in a phase III trial of the Swedish
- Gemcitabine induction chemotherapy in non-small cell lung cancer.
- Present and future treatment of advanced non-small cell lung cancer.
- Economic evaluation of gemcitabine alone and in combination with cisplatin in the treatment of nonsmall cell lung cancer.
- Study shows 2-year survival advantage for docetaxel.
- Novuspharma announces preliminary results of phase II trials for BBR 3464.
- A phase I study of combination chemotherapy with gemcitabine and oral UFT for advanced non-small cell lung cancer.
- The quality of life questionnaire for cancer patients treated with anticancer drugs (QOL-ACD): validity and reliability in japanese
Table of Contents
1
UI - 11377599
AU - Georgoulias V; Papadakis E; Alexopoulos A; Tsiafaki X; Rapti A; Veslemes
TI -
M; Palamidas P; Vlachonikolis I; Greek Oncology Cooperative Group (GOCG)
for Lung Cancer
Platinum-based and non-platinum-based chemotherapy in advanced
non-small-cell lung cancer: a randomised multicentre trial.
SO - Lancet 2001 May 12;357(9267):1478-84
AD - Department of Medical Oncology, University General Hospital of
Heraklion, POBox 1352, Heraklion 71110, Crete, Greece.
georgsec@med.uch.gr
BACKGROUND: Docetaxel in combination with cisplatin or gemcitabine are
active chemotherapy reigimes against non-small-cell lung cancer. We
compared the efficacy and safety of a combination of cisplatin and
docetaxel (group 1) with that of gemcitabine and docetaxel (group 2) in
the treatment of advanced non-small-cell lung cancer in a prospective,
randomised, multicentre trial. METHODS: Patients with stage IIIB or IV
lung cancer who had not had prior chemotherapy were allocated either to
group 1 and treated with docetaxel (100 mg/m(2), day 1) and cisplatin
(80 mg/m(2), day 2) or to group 2 and treated with gemcitabine (1100
mg/m(2), days 1 and 8) and docetaxel (100 mg/m(2), day 8). All patients
received recombinant human granulocyte colony-stimulating factor (150
mg/m(2)). All patients received recombinant human granulocyte
colony-stimulating factor (150 mg/m(2)) had appropriate standard
premedication. Response and toxicity were assessed using WHO criteria.
Analysis was by intention to treat. FINDINGS: 441 patients were randomly
assigned to receive docetaxel/cisplatin (group 1, n=219) or
gemcitabine/docetaxel (group 2, n=222). 14 patients in group 1 and 21
patients in group 2 were not evaluable. Objective response rates were
similar in the two groups: group 1, 32.4% (95% CI 26.2-38.6%; 1.4%
complete response and 31% partial response); group 2, 30.2% (24.5-36.2%;
0.9% complete response and 29.3% partial response). The two groups did
not differ in median duration of response, time to tumour progression,
overall survival, or 1 year or 2 year survival rates. INTERPRETATION:
Both drug combinations had comparable activity in patients with advanced
cancer who had not previously had chemotherapy; however, gemcitabine and
docetaxel had the most favourable toxicity profile.
2
UI - 11675089
AU - Satoh H; Sekizawa K
TI -
Chemotherapy for non-small-cell lung cancer.
SO - Lancet 2001 Oct 13;358(9289):1270-1; discussion 1271-2
3
UI - 11675091
AU - van Meerbeeck JP; Legrand C; van Klaveren RJ; Giaccone G; EORTC Lung
TI -
Cancer Group
Chemotherapy for non-small-cell lung cancer.
SO - Lancet 2001 Oct 13;358(9289):1271-2
4
UI - 11880710
AU - Booton R; Thatcher N
TI -
Chemotherapy in advanced nonsmall cell lung cancer: indication,
intensity, and duration.
SO - Curr Opin Oncol 2002 Mar;14(2):191-8
AD - CRC Department of Medical Oncology, Christie Hospital NHS Trust,
Manchester, United Kingdom.
Platinum-based combination and single-agent chemotherapy have become
accepted as treatments for locally advanced and metastatic nonsmall cell
lung cancer as a consequence of improved survival, quality of life, and
symptom control compared with best supportive care. However, it is clear
that a therapeutic plateau has been reached with current combinations
requiring a re-evaluation of strategies to improve clinical outcomes.
Dose intensification may offer one way in which to achieve better
results, as may extension of the duration of treatment. The evidence
suggests that dose intensification is a useful tool, and that its use in
combination with markers of treatment duration and cumulative dose may
help to maximize results from current active drug combinations.
5
UI - 11880711
AU - Gridelli C; Maione P; Barletta E
TI -
Individualized chemotherapy for elderly patients with nonsmall cell lung
cancer.
SO - Curr Opin Oncol 2002 Mar;14(2):199-203
AD - Division of Medical Oncology B, National Cancer Institute, Naples,
Italy. cgridelli@sirio-oncology.it
Approximately one third of all patients with nonsmall cell lung cancer
(NSCLC) are over the age of seventy. Elderly patients tolerate
chemotherapy poorly because of impaired organ function and
comorbidities. For this reason, these patients are often not considered
eligible for aggressive cisplatin-based chemotherapy. A multidimensional
geriatric evaluation is important to plan appropriate treatments. At
present, there are no indications for adjuvant and neoadjuvant
chemotherapy. Combined chemoradiotherapy in locally advanced disease
increases toxicity and seems determine no survival advantage as compared
with radiation therapy alone. In advanced disease, single-agent
vinorelbine proves to be active and well-tolerated, and compared with
best supportive care, improves survival and perhaps quality of life.
Gemcitabine is active and also well tolerated. Taxanes are in advanced
phase of evaluation. A phase III randomized trial showed that
polychemotherapy with gemcitabine and vinorelbine does not improve any
outcome as compared with single-agent chemotherapy with vinorelbine or
gemcitabine. In clinical practice, single-agent chemotherapy should
remain the standard treatment. The choice of the drug should be based on
the toxicity profile of each drug and type of comorbid conditions. In
the near future, new therapeutic strategies and biologic agents could
improve present results.
6
UI - 11895896
AU - Hahm HA; Ettinger DS; Bowling K; Hoker B; Chen TL; Zabelina Y; Casero RA
TI -
Jr
Phase I study of N(1),N(11)-diethylnorspermine in patients with
non-small cell lung cancer.
SO - Clin Cancer Res 2002 Mar;8(3):684-90
AD - The Johns Hopkins Oncology Center, Baltimore, Maryland 21231, USA.
PURPOSE: Polyamines are essential for tumor growth; consequently, agents
that interfere with their metabolisms have been developed as
antineoplastic agents. Diethylnorspermine (DENSPM) is one such agent. A
focused Phase I clinical trial in patients with advanced non-small cell
lung cancer was undertaken. EXPERIMENTAL DESIGN: Twenty-nine patients
were treated with DENSPM using a dosing schedule of once daily for 5
days. Doses ranged from 25 mg/m(2)/day to 231 mg/m(2)/day. RESULTS: The
dose-limiting toxicity was determined to be gastrointestinal including
asthenia, abdominal cramps, diarrhea, and nausea. The maximal tolerated
dose was 185 mg/m(2)/day for 5 days. At drug dosages for which it was
possible to estimate, serum half-life ranged from 0.5 to 3.7 h without
apparent dose dependence. Maximal serum concentrations increased with
dosage. However, the increase was greater than the proportional increase
of the administered dose. There were no objective disease responses
observed during the Phase I trial. CONCLUSIONS: The results of the Phase
I clinical trial suggest that DENSPM can safely be administered to
patients with minimal toxicity. Furthermore, the observed dose-limiting
toxicity is unique to DENSPM, thus underscoring the potential for DENSPM
to be a suitable agent for chemotherapy in combination with agents
possessing different spectrums of toxicities.
7
UI - 12066454
AU - Sobel RK
TI -
Cancer medicine hits a target.
SO - US News World Rep 2002 Jun 3;132(19):54
8
UI - 10931451
AU - Paesmans M; Sculier JP; Lecomte J; Thiriaux J; Libert P; Sergysels R;
TI -
Bureau G; Dabouis G; Van Cutsem O; Mommen P; Ninane V; Klastersky J
Prognostic factors for patients with small cell lung carcinoma: analysis
of a series of 763 patients included in 4 consecutive prospective trials
with a minimum follow-up of 5 years.
SO - Cancer 2000 Aug 1;89(3):523-33
AD - Institut Jules Bordet, Brussels, Belgium.
BACKGROUND: The purposes of this study were to identify prognostic
factors for response to chemotherapy, overall survival, and long term
survival of patients with small cell lung carcinoma and to construct a
classification of patients on the basis of their expected overall
survival. METHODS: In the 763 patients registered in 4 consecutive
clinical trials conducted by the European Lung Cancer Working Party from
1982 to 1993, the impact of 21 pretreatment variables assessable in a
routine practice was analyzed for the various outcomes with a minimum
follow-up of 5 years. RESULTS: The key prognostic role of disease extent
was confirmed for all the outcomes. Additional independent prognostic
factors for response to chemotherapy were gender, neutrophil count, and
hemoglobin level; for overall survival, these factors were Karnofsky
performance status, gender, and neutrophil count. Recursive partitioning
and amalgamation algorithms (RECPAM) analysis classified patients into 4
groups, taking into consideration disease extent, Karnofsky performance
status, age, gender, and neutrophil count. Median survival times for the
4 groups were 60, 47, 36, and 28 weeks, respectively. For long term
survival, defined as a minimum survival of 2 years (9% of the patients),
Karnofsky performance status was the only independent predictive factor,
along with the achievement of a complete response (if this was taken
into consideration). Small cell lung carcinoma remained the main cause
of death among these patients. Cure was infrequent, with only 14
patients alive and disease free at 5 years (1.8%). CONCLUSIONS: In this
study the long term prognosis associated with small cell lung carcinoma
was poor. The well-known prognostic values of disease extent and
Karnofsky performance status were confirmed, but the authors also
identified age and gender (which are more controversial) as independent
characteristics, in addition to citing the role of complete response in
the attainment of long term survival. The independent role of
neutrophils observed by the authors. must be validated by further
studies. Copyright 2000 American Cancer Society.
9
UI - 11955650
AU - Gajra A; Tatum AH; Newman N; Gamble GP; Lichtenstein S; Rooney MT;
TI -
Graziano SL
The predictive value of neuroendocrine markers and p53 for response to
chemotherapy and survival in patients with advanced non-small cell lung
cancer.
SO - Lung Cancer 2002 May;36(2):159-65
AD - Department of Medicine, SUNY Upstate Medical University, Syracuse, NY
13210, USA.
BACKGROUND: A minority of patients (30-40%) with advanced non-small cell
lung cancer (NSCLC) have objective responses to chemotherapy. Therefore,
defining molecular features that determine resistance or response to
chemotherapy would have important implications in this disease. Several
studies have suggested that patients whose tumors have neuroendocrine
features may be more responsive to chemotherapy. In addition, increased
expression of p53 may play a role in chemotherapy resistance in patients
with NSCLC. METHODS: The objective of this study was to analyze
retrospectively, the correlation between marker expression and response
to chemotherapy and survival using immunohistochemistry for
neuroendocrine markers and p53. Ninety patients with unresectable stage
III or IV NSCLC, treated with platinum based combination chemotherapy
were evaluated. The pathological specimens were obtained prior to
chemotherapy. RESULTS: There was no statistically significant
correlation between any individual marker and response to chemotherapy.
However, patients with tumors with increased expression of p53 were more
likely to have progressive disease following chemotherapy (P=0.02).
Similarly, patients with tumors lacking neuroendocrine expression and
with increased expression of p53 were more likely to have progressive
disease when compared to patients with tumors with normal p53 expression
and neuroendocrine differentiation (P=0.03). Normal expression of p53
along with the presence of neuroendocrine differentiation was a
favorable factor for both survival (P=0.05) and time to disease
progression (P=0.04) in the multivariate analysis. CONCLUSION: The
presence of neuroendocrine markers alone was not predictive of response
to chemotherapy and did not impact on the survival of this group of
patients with advanced stage NSCLC. The normal expression of p53
together with neuroendocrine differentiation seems to impact favorably
on overall survival time and time to disease progression without
significant improvement in response to chemotherapy.
10
UI - 11955653
AU - Manegold C; Buchholz E; Kloeppel R; Kreisel C; Smith M
TI -
Phase I dose-escalating study of raltitrexed ('Tomudex') and cisplatin
in metastatic non-small cell lung cancer.
SO - Lung Cancer 2002 May;36(2):183-9
AD - Thorax-Klinik Heidelberg GmbH, Innere Medizin/Onkologie, Amalienstr. 5,
Germany. prof.manegold@t-online.de
BACKGROUND: The aim of this Phase I, dose-escalation study was to
determine the maximum tolerated dose (MTD), recommended dose (RD), and
dose-limiting toxicity (DLT) of a raltitrexed ('Tomudex') and cisplatin
combination in patients with previously untreated, metastatic non-small
cell lung cancer (NSCLC). PATIENTS AND METHODS: Patients received
raltitrexed (15-min intravenous infusion), followed by cisplatin (1-h
intravenous infusion), every 3 weeks at escalating dose levels. Results:
In total, 21 patients entered the study. No DLT was observed up to dose
level 4 (raltitrexed 3.0 mg/m(2) plus cisplatin 80 mg/m(2)), or in the
first 3 patients who received dose level 5 (raltitrexed 3.5 mg/m(2) plus
cisplatin 80 mg/m(2)). However, 1 patient, entered at dose level 6
(raltitrexed 4.0 mg/m(2) plus cisplatin 80 mg/m(2)) experienced severe
toxicity (including grade 3 diarrhea), and no further patients were
recruited at this level. Of 4 additional patients who received
raltitrexed 3.5 mg/m(2) plus cisplatin 80 mg/m(2), 3 also experienced
DLTs. The most common adverse events included nausea/vomiting, asthenia,
diarrhea, and hematologic toxicities. Of 19 patients evaluated for
response, 3 achieved a partial response, 13 had stable disease, and 3
progressed. CONCLUSIONS: The MTD is raltitrexed 3.5 mg/m(2) plus
cisplatin 80 mg/m(2), and the RD for future studies is raltitrexed 3.0
mg/m(2) plus cisplatin 80 mg/m(2); DLTs were diarrhea and asthenia. The
combination of raltitrexed and cisplatin shows clinical activity in
patients with metastatic NSCLC.
11
UI - 11955654
AU - Thomas P; Robinet G; Ferri-Dessens RM; Lena H; Gouva S; Vernejoux JM;
TI -
Kleisbauer JP
Phase I trial of gemcitabine and carboplatin in metastatic
non-small-cell lung cancer: a Groupe Francais de Pneumo-Cancerologie
Study.
SO - Lung Cancer 2002 May;36(2):191-8
AD - Service d'Oncologie Respiratoire, Hopital Sainte-Marguerite, 270 Bd
Sainte-Marguerite, 13 009 Marseille, France. pneumologie@ch-gap.fr
BACKGROUND: The purpose of this study was to determine the
maximum-tolerated dose (MTD) and the dose-limiting toxicity (DLT) of the
21 days carboplatin plus gemcitabine regimen in previously untreated
patients with stage IV non small-cell lung cancer (NSCLC). METHODS: At
least three patients were entered at each dose level. The starting dose
was carboplatin AUC 4 mg/ml per min (Area Under the Curve; Calvert
formula) on day 1 and gemcitabine 750 mg/m(2) on days 1 and 8.
Carboplatin was increased to AUC 5 (level 3, 4) then to AUC 6 (level
5-7). Gemcitabine was increased to 875 (level 2, 3), 1000 (level 4, 5),
1250 (level 6) and finally 1500 mg/m(2) (level 7). Twenty-nine patients
were entered into this phase I study. RESULTS: At dose level 6, a DLT
(grade 4 thrombocytopenia) was observed in one out of six patients. At
dose level 7, no DLT was observed during the first course, so the MTD
was not reached. During the second course, two out of four patients
presented grade 4 thrombocytopenia. None of the five patients receiving
two courses at level 6 presented a DLT, so this level was retained for
further phase II studies. Of the 25 patients assessable for response,
five achieved partial responses with a response rate of 20% (95% CI, 7
to 41%). The median survival time was 7 months and the 1-year survival
rate was 24% (95% CI, 9 to 45%). CONCLUSION: The combination of
carboplatin given on day 1 and gemcitabine given on days 1 and 8 every 3
weeks seems to be an acceptable regimen. The DLT consists exclusively of
severe thrombocytopenia. Despite the MTD was not reached with
carboplatin AUC 6 mg/ml per min and gemcitabine 1500 mg/m(2), the
recommended dose for further phase II studies is carboplatin AUC 6 mg/ml
per min and gemcitabine 1250 mg/m(2).
12
UI - 11955659
AU - Dediu M
TI -
Is long term gemcitabine useful in small cell lung cancer?
SO - Lung Cancer 2002 May;36(2):217-8
13
UI - 12088266
AU - Frassineti GL; Ibrahim T; Zoli W; Monti M; Ricotti L; Nanni O; Amadori D
TI -
Docetaxel followed by gemcitabine in the treatment of advanced non-small
cell lung cancer: a phase I study.
SO - Tumori 2002 Mar-Apr;88(2):99-103
AD - Department of Medical Oncology, Pierantoni Hospital, Forli, Italy.
AIMS AND BACKGROUND: Based on the results of a preclinical study, a
phase I trial was conducted to evaluate the feasibility of administering
docetaxel followed by gemcitabine in non-small cell lung cancer
patients. STUDY DESIGN: Sixteen patients with advanced non-small cell
lung cancer (stages III B-IV) were treated on the 1st day with docetaxel
and on the 8th day with gemcitabine. Treatment was repeated every three
weeks for a maximum of six cycles. Five groups received
docetaxel/gemcitabine (mg/ml): 50/800, 60/800, 60/900, 60/1,000,
70/1,000. All patients and 57 cycles were assessed for toxicity.
RESULTS: The most important side effects were grade IV neutropenia in 4
patients (2 at the 60/1000 level and 2 at the 70/1000 level) and grade
III leukopenia and neutropenia without fever in 4 and 6 patients,
respectively. Maximum tolerated dose was not reached. CONCLUSIONS: The
sequence docetaxel-gemcitabine appears well tolerated and easy to
administer. For this reason, a phase II study is ongoing to fully assess
its antitumor activity.
14
UI - 12042986
AU - Baldini E; Ardizzoni A; Prochilo T; Cafferata MA; Boni L; Tibaldi C
TI -
Gemcitabine, ifosfamide and Navelbine (GIN): a platinum-free combination
in advanced non-small-cell lung cancer (NSCLC).
SO - Cancer Chemother Pharmacol 2002 May;49 Suppl 1():S25-8
AD - U.O. Oncologia Medica Ospedale S. Chiara, via Roma n.67, 56100 Pisa,
Italy. e.baldini@do.med.unipi.it
PURPOSE: To evaluate the activity and toxicity of gemcitabine,
ifosfamide and Navelbine (GIN) in advanced NSCLC. PATIENTS AND METHODS:
Stage IIIB/IV NSCLC, WHO performance status <2 and bidimensionally
measurable disease were required to enter the study. Gemcitabine 1000
mg/m(2) day 1 and 1000 or 800 mg/m(2) day 4, ifosfamide 3 g/m(2) day 1
(with mesna), Navelbine 25 mg/m(2) day 1 and 25-20 mg/m(2) day 4 were
administered on an outpatient basis every 3 weeks for a maximum of six
courses. Objective remissions (ORs) were evaluated every two courses.
According to Simon's optimal two-stage design, more than 18 ORs out of
54 patients were required to establish the activity of this regimen.
RESULTS: The study group comprised 50 patients. Most patients had
metastatic disease (79%) and nonsquamous histology (71%). The total
number of courses administered was 200, with a median per patient of 4
(range 1-6). Myelosuppression, in particular leukopenia, was the most
frequent toxicity: grade 3-4 neutropenia (WHO) occurred in 47% of the
courses, while grade 3-4 thrombocytopenia and anemia affected,
respectively, 6.6% and 3.5% of the courses only. Twelve episodes of
febrile neutropenia were recorded, and three patients required hospital
admission. No toxic deaths were reported. Nonhematological toxicity was
generally mild and not clinically relevant. A total of 25 ORs (1
complete response and 24 partial responses) were obtained for a response
rate of 52% (95% CI 37.4-66.5%). One-year survival was 46.5%.
CONCLUSIONS: The GIN combination showed promising activity against NSCLC
with myelosuppression, in particular neutropenia, being dose limiting.
This non-platinum-based triplet may be a valuable alternative to
standard platinum-containing regimens and it is under evaluation in an
ongoing randomized trial.
15
UI - 11824892
AU - Price A
TI -
Chemotherapy in patients with advanced non-small cell lung cancer.
SO - Clin Oncol (R Coll Radiol) 2001;13(6):480-2
16
UI - 11824893
AU - Gregory RK; Smith IE; Norton A; Ashley S; O'Brien ME
TI -
Mitomycin C, vinblastine and carboplatin: effective outpatient
chemotherapy for advanced non-small cell carcinoma of the lung (NSCLC).
SO - Clin Oncol (R Coll Radiol) 2001;13(6):483-7
AD - Royal Marsden Hospital, Sutton, UK.
The majority of patients diagnosed with non-small cell lung carcinoma
(NSCLC) present with advanced disease and, as such, are treated with
palliative intent. Platinum-based combination chemotherapy plays an
important role in the management of these patients, with response rates
to most regimens being in the range of 30%-40%. with symptom relief in
up to 60%. One of the most commonly utilized combinations is mitomycin
C, vinblastine and cisplatin (MVP). Owing to the hydration regimen, and
to the age and performance status of many of these patients, in reality
this combination often necessitates an overnight stay in hospital. A
combination of drugs that could be administered as an outpatient would
be beneficial to patients and could result in substantial economic
benefits. Forty-three patients with Stage IlIb and IV NSCLC were treated
with the MVCarbo regimen, in which the cisplatin in the MVP regimen was
replaced with carboplatin. All treatment was administered on an
outpatient basis. The overall objective response rate was 30%; the
symptomatic response rate was 60%, which was exactly equivalent to the
response rate seen in a comparable group of patients treated with MVP in
a trial on duration of chemotherapy at the Royal Marsden Hospital. There
was no difference in progression-free or overall survival between
patients treated with the two regimens. The MVCarbo regimen resulted in
response rates and survival rates equivalent to those seen with standard
MVP and, as such, provides an acceptable outpatient alternative to this
treatment.
17
UI - 12109452
AU - Yamamoto N; Fukuoka M
TI -
[Guideline for chemotherapy of malignant lung cancer]
SO - Gan To Kagaku Ryoho 2002 Jun;29(6):985-1007
18
UI - 12089222
AU - Hainsworth JD; Gray JR; Morrissey LH; Kalman LA; Hon JK; Greco FA
TI -
Long-term follow-up of patients treated with
paclitaxel/carboplatin-based chemotherapy for advanced non-small-cell
lung cancer: sequential phase II trials of the Minnie Pearl Cancer
Research Network.
SO - J Clin Oncol 2002 Jul 1;20(13):2937-42
AD - Sarah Cannon Cancer Center and Tennessee Oncology, PLLC, Nashville, TN
37203, USA.
PURPOSE: To provide long-term follow-up on the survival of patients with
advanced non-small-cell lung cancer treated with
paclitaxel/carboplatin-based regimens in a multicenter, community-based
patients with newly diagnosed stage IIIB or IV non-small-cell lung
cancer were treated on sequential phase II trials with the following
combination regimens: paclitaxel/carboplatin,
paclitaxel/carboplatin/gemcitabine, and
paclitaxel/carboplatin/vinorelbine. Details of these three regimens and
patient populations have been previously reported. Responding and stable
patients continued treatment until tumor progression or for a
recommended six treatment courses. RESULTS: After a median follow-up of
58 months (minimum follow-up, 40 months), the median survival for the
entire group of patients was 8.6 months, with actual 1-, 2-, and 3-year
survival rates of 40%, 19%, and 7%, respectively. The actuarial 4-year
survival rate for the entire group was 4%. No statistically significant
differences in survival were seen among the three regimens.
Administration of all three regimens was feasible in a community-based
setting; however, myelosuppression and hospitalizations for treatment of
neutropenia/fever were more frequent with the three-drug regimens.
CONCLUSION: Paclitaxel/carboplatin-based regimens, in addition to
prolonging median survival and improving 1-year survival, result in
substantial improvements in the 2-year survival of patients with
advanced non-small-cell lung cancer when compared retrospectively with
supportive care or traditional cisplatin-based regimens. In these
sequential phase II trials, we did not demonstrate any advantages of
three-drug regimens when compared with paclitaxel/carboplatin. Because
few patients remain alive after 4 years with any of these chemotherapy
regimens, future treatment improvements will require the introduction of
novel agents.
19
UI - 11822756
AU - Huisman C; Postmus PE; Giaccone G; Smit EF
TI -
A phase I study of sequential intravenous topotecan and etoposide in
lung cancer patients.
SO - Ann Oncol 2001 Nov;12(11):1567-73
AD - Department of Pulmonary, University Hospital Vrije Universiteit,
Amsterdam, The Netherlands.
PURPOSE: The topoisomerase I inhibitor topotecan (T) and the
topoisomerase II inhibitor etoposide (E) are active drugs in lung
cancer. The complementary functions of their targets may suggest benefit
from the combined use of these agents but drug scheduling has been shown
to play a critical role in preclinical models. To establish the optimal
schedule and assess the impact of sequential administration of the
combination of T and E, we conducted a dose finding study of sequential
intravenous T and E in a four-weekly-schedule in relapsed lung cancer
patients. PATIENTS AND METHODS: The importance of drug sequence was
assessed in consecutive patients throughout all dose levels; patients
received in the first course either T followed by E (the TE group: T on
days 1-3 and E on days 4-6) or E before T (the ET group: F on days 1-3
and Ton days 4-6). The sequence of Tand E was alternated in the
successive courses. In this crossover design, each patient served as his
own control for analysis of hematological toxicity in which TE sequence
was compared to that of the ET sequence. Moreover, hematological
toxicity after the first course was compared between the TE and the ET
groups. The starting dose was T/E 0.75/75 mg/m2 at dose level 1and dose
escalation was planned to T/E 1.00/75 mg/nm2 at dose level 2, T/E
1.00/100 mg/m2 at dose level 3, T/E 1.25/100 mg/m2 at dose level 4 and
T/E 1.50/100 mg/m2 at dose level 5. Nineteen patients (small-cell lung
cancer 7, non-small-cell lung cancer 11, mesothelioma 1 patient) were
included. RESULTS: The principal toxicity was myelosuppression,
primarily neutropenia and thrombocytopenia. At dose level 3 several
grade 4 toxicities were observed. DLT (febrile neutropenia) occurred in
two patients, one in the TE and one in the ET group and precluded
further dose escalation. There was no significant difference in WBC and
platelet nadirs during the first course between the TE and the ET group.
The influence of the sequence of administration of topotecan and
etoposide was calculated by comparing the nadir values of cycles I and
II for each patient. For none of the dose levels, a significant
sequence-dependent effect could be detected. The MTD was reached at the
doses of 100 mg/m2 topotecan and 75 mg/m2 etoposide. No objective
responses were seen. CONCLUSION: Although the combined use of
topoisomerase I and II inhibitors is attractive on theoretical grounds,
excessive myelosuppression prevents substantial dose escalation.
20
UI - 11829085
AU - Osterlind K
TI -
Chemotherapy in small cell lung cancer.
SO - Eur Respir J 2001 Dec;18(6):1026-43
AD - Dept of Oncology, Herlev University Hospital, Denmark.
Chemotherapy is the backbone in the treatment of small cell lung cancer
(SCLC) and radiotherapy is an important adjunct in limited stage
disease. The role of chest irradiation is now documented in three
meta-analysis, based on the same body of data. Trials on timing,
scheduling and fractionation could have followed a more stringent
development line but altogether, the highest efficacy seems to be
obtained with early, concurrent twice-daily chest irradiation. Patients
in complete remission should have prophylactic cranial irradiation,
which reduces the risk of brain metastases and of death from SCLC. Four
series of chemotherapy seem to be sufficient in limited-stage disease
while six is recommended in extensive disease. The combination of
etoposide plus cis- or carboplatin is appropriate in both stages and
addition of other agents has no clinically important impact on the
survival. Use of haematological growth factors such as granulocyte
colony stimulating factor (G-CSF) and granulocyte macrophage colony
stimulating factor (GM-CSF) may enable higher doses or more frequent
dosage. Three randomized trials on GM-CSF showed a negative outcome
while G-CSF support may result in better survival rates, but a more
cost-efficient policy must be found. High-dose chemotherapy plus
haematological stem-cell support is still under investigation but
disappointing long-term survival rates means there is not much optimism
for this strategy. New strategies in general are requested in the
treatment of extensive-stage disease and of elderly patients. Phase II
trials suggest that good-risk patients with extensive disease should be
treated aggressively, intermediate-risk patients more gently, and
palliation must be the primary aim in the treatment of poor-risk
patients. In elderly patients impressive survival rates are obtained
with 3-4 series of chemotherapy and radiation delivered in 5-10
fractions. A number of new agents are active but more trials are
required before each has found a place, if any, in the treatment of
small cell lung cancer. To conclude, the randomized trial is still an
important instrument in clinical oncology, and trials in small cell lung
cancer must be large, which is why the cooperation of organizations and
multicentres is urgent.
21
UI - 12057138
AU - Cohen EE; Vokes EE
TI -
Locally advanced non-small cell lung cancer.
SO - Curr Treat Options Oncol 2001 Feb;2(1):27-42
AD - Section of Hematology and Oncology, Department of Medicine, The
University of Chicago, 5841 S. Maryland Avenue, Chicago, IL 60637, USA.
Locally advanced non-small cell lung cancer remains a paradoxical entity
to manage. Although this type of cancer is confined to the thorax and is
ostensibly curable, most patients presenting at this stage of disease
eventually succumb to it. The accepted therapy presently includes
chemotherapy and radiation. The exact agents, schedules, and
combinations need to be defined further, although cisplatin has become
the widely viewed standard cytotoxic drug in this setting.
Notwithstanding, newer chemotherapeutic and biologic agents are being
extensively tested to find less toxic options with greater efficacy.
Drugs that are gaining widespread approval include carboplatin,
paclitaxel, gemcitabine, and vinorelbine. At the same time, advances in
radiation therapy are triggering a revolution in dose intensity and
scheduling that will one day offer superlative local control.
22
UI - 12057139
AU - Wright CD; Mathisen DJ
TI -
Superior sulcus tumors.
SO - Curr Treat Options Oncol 2001 Feb;2(1):43-9
AD - General Thoracic Surgical Unit, Massachusetts General Hospital, 55 Fruit
Street, Boston, MA 02114, USA.
Superior sulcus tumors (also known as Pancoast's tumors) are an unusual
presentation of non-small cell lung cancer (NSCLC) that are often
initially misdiagnosed. Accurate and thorough staging is necessary prior
to treatment and typically includes magnetic resonance imaging if a
surgical approach is being considered. Standard therapy has been
induction radiation therapy followed by resection, which results in a
5-year survival of about 30%. Complete resection remains the key to
long-term survival in localized NSCLC but is difficult to achieve with
superior sulcus tumors due to early invasion of bone and to vascular and
nervous structures at the apex of the chest. Complete resection has been
enhanced by using an anterior trans-cervicomediastinal approach that
facilitates resection of anterior-based tumors that invade the
subclavian vessels. Recently, induction chemoradiotherapy has been
reported to enhance complete resection rates and improve survival
compared with historical controls and is likely to become the new
standard treatment for localized superior sulcus tumors.
23
UI - 12057140
AU - Edelman MJ; Khanwani SL
TI -
Advanced non-small cell lung cancer.
SO - Curr Treat Options Oncol 2001 Feb;2(1):51-62
AD - University of Maryland Greenebaum Cancer Center, 22 S. Greene Street,
Baltimore, MD 21201-1595, USA.
The treatment of advanced non-small cell lung cancer requires histologic
proof of diagnosis, careful staging, and assessment of each patient's
performance status and comorbidities. For patients with stage IIIB
(pleural effusion) and stage IV disease who have a Cancer and Leukemia
Group B performance status (PS) of 0 to 1, appropriate management
consists of combination chemotherapy with a platinum (either cisplatin
or carboplatin) combined with paclitaxel, gemcitabine, vinorelbine,
docetaxel, or CPT-11. Dosages and schedules previously established by
large phase II or phase III studies should be followed. Variations in
the toxicity patterns, schedules of administration, and economic
considerations should guide the selection of the specific regimen. For
patients who maintain a good performance status after first-line
chemotherapy, second-line treatment may be considered. Current evidence
supports the use of docetaxel as second-line treatment if the patient
has not previously received this drug. Gemcitabine and paclitaxel may
also have activity in this setting. Vinorelbine, ifosfamide, and CPT-11
appear to be inactive as second-line therapy for patients who have
previously received platinum-based chemotherapy. For patients with a PS
of 2, single-agent chemotherapy with vinorelbine, gemcitabine, or a
combination of the two should be considered. Patients with poor
performance status should be treated with supportive measures designed
to relieve pain and acute complications because any tumor-directed
therapy has limited benefit. Special situations exist in which curative
therapy for metastatic disease is a possibility. Patients who present
with solitary sites of metastatic disease, particularly after a long
disease-free interval and in the CNS may undergo definitive surgery or
radiotherapy with curative intent. Some have also reported favorable
outcomes for patients with solitary adrenal or bone metastases as well.
Surgical treatment or definitive radiotherapy should not be employed
unless a thorough restaging evaluation is performed that includes
computed tomography scan of the chest and abdomen through adrenals,
brain magnetic resonance imaging, and positron emission tomography scan.
A plethora of new agents targeting angiogenesis, tumor invasiveness, the
hypoxic environment of tumors, and the cell cycle are currently in
development.
24
UI - 12057141
AU - Murray N; Sheehan F
TI -
Limited stage small cell lung cancer.
SO - Curr Treat Options Oncol 2001 Feb;2(1):63-70
AD - British Columbia Cancer Agency, 600 West 10th Avenue, Vancouver, British
Columbia, Canada V5Z 4E6.
The management of limited stage small cell lung cancer begins with a
firm pathologic diagnosis and careful staging. Patients with adequate
pulmonary function, ambulatory performance status, and no evidence of
metastatic disease outside a "tolerable" local radiotherapy volume
should have consultation from both medical and radiation oncology
disciplines for planning of integrated therapy. The chemotherapy
prescription recommended is cisplatin plus etoposide at standard doses
for four chemotherapy cycles. Thoracic irradiation should be
administered concurrently with the first or second cycle of cisplatin
and etoposide. Patients with complete response and excellent partial
response should receive prophylactic cranial irradiation after
completion of all chemotherapy.
25
UI - 12057142
AU - Niell HB
TI -
Extensive stage small cell lung cancer.
SO - Curr Treat Options Oncol 2001 Feb;2(1):71-6
AD - Van Vleet Cancer Center, University of Tennessee-Memphis, 3N Dunlap,
Memphis, TN 38163, USA.
Small cell lung cancer is a rapidly proliferating, biologically
aggressive form of lung cancer that has a short survival without
treatment. Chemotherapy is the foundation of the therapeutic approach to
patients with small cell lung cancer. Most patients present with
extensive disease, and, although few patients are cured, significant
improvement in survival is possible with modern chemotherapy. The role
of radiation therapy in extensive disease is palliative, and surgery has
little role in patient management. The standard chemotherapy regimen for
patients with small cell lung cancer has become either cisplatin or
carboplatin with etoposide. Second-line chemotherapy regimens are
moderately effective in patients previously responding to initial
chemotherapy. Newer chemotherapy agents show promise, but few randomized
trials have been completed in extensive disease. Physicians should be
encouraged to include their patients with extensive small cell lung
cancer in the evolving clinical trials.
26
UI - 12057087
AU - Lara PN Jr; Lau DH; Gandara DR
TI -
Non-small-cell lung cancer progression after first-line chemotherapy.
SO - Curr Treat Options Oncol 2002 Feb;3(1):53-8
AD - Division of Hematology-Oncology, Department of Internal Medicine,
University of California Davis Cancer Center, 4501 X Street, Sacramento,
CA 95817, USA. primo.lara@ucdmc.ucdavis.edu
Platinum-based chemotherapy is the cornerstone of care for patients with
metastatic non-small-cell lung cancer (NSCLC). It provides symptom
relief, improved quality of life, and prolongation of life, compared
with supportive care alone. However, all patients with stage IV disease
inevitably develop resistance to chemotherapy and progressive disease.
Many of these patients continue to have acceptable performance status
and would therefore be eligible for second-line or even third-line
treatments. Unfortunately, despite an increasing number of
chemotherapeutic agents (which are effective in chemo-naive NSCLC), very
few have been shown to have reproducible activity in the second-line
setting. Nevertheless, recent randomized clinical trials have
demonstrated that single-agent docetaxel improves survival and quality
of life when delivered as second-line therapy, resulting in FDA-approval
for this indication. Phase II studies evaluating other new agents,
delivered singly or in combination, also have reported that gemcitabine,
weekly paclitaxel, and the epidermal growth factor receptor (EGFR)
inhibitors are active in a subset of patients who progress after
first-line platinum-based therapy. Clinical trials are imperative in
identifying additional new agents and approaches that may improve
outcomes in this disease. In view of the recently established role of
docetaxel, ongoing randomized studies are using a common design of
single-agent docetaxel versus docetaxel plus a novel investigational
agent.
27
UI - 11963726
AU - Schalhorn A
TI -
[Modern chemotherapy in bronchial carcinoma]
SO - Internist (Berl) 2002 Mar;43(3):416-30
AD - Medizinische Klinik III, Ludwig-Maximilians-Universitat, Klinikum
Grosshadern, Marchioninistrasse 15, 81377 Munchen.
28
UI - 12065869
AU - Ueno H; Okada S; Okusaka T; Ikeda M; Kuriyama H
TI -
Phase II study of uracil-tegafur in patients with metastatic pancreatic
cancer.
SO - Oncology 2002;62(3):223-7
AD - Hepatobiliary and Pancreatic Oncology Division, National Cancer Center
Hospital, Tokyo, Japan. hiueno@ncc.go.jp
OBJECTIVE: Uracil-tegafur (UFT) has been reported to have a broad
anti-tumor activity in a variety of malignancies including colorectal
cancer and breast cancer. However, its activity in pancreatic cancer has
not been fully evaluated. The aim of the present study was to evaluate
the anti-tumor activity and toxicity of UFT in patients with metastatic
pancreatic cancer. METHODS: All patients were required to have a
pathologic diagnosis of pancreatic adenocarcinoma with measurable
metastatic lesions, and no prior chemotherapy. A dose of 360 mg/m2/day
of UFT was administered orally until the appearance of disease
progression or unacceptable toxicity. RESULTS: Twenty-two patients were
entered into this study. Of 21 patients evaluable for response, no
patient achieved an objective tumor response; one showed no change, and
the remaining 20 showed progressive disease. The median survival time
for all patients was 4.2 (range: 0.9-9.0) months. The most common
toxicities were nausea/vomiting and anorexia. Five patients (23%) had to
discontinue UFT treatment because of gastrointestinal toxicity.
CONCLUSION: This schedule of UFT did not demonstrate a significant
anti-tumor activity against metastatic pancreatic cancer. Copyright 2002
S. Karger AG, Basel
29
UI - 12065068
AU - Clegg A; Scott DA; Sidhu M; Hewitson P; Waugh N
TI -
A rapid and systematic review of the clinical effectiveness and
cost-effectiveness of paclitaxel, docetaxel, gemcitabine and vinorelbine
in non-small-cell lung cancer.
SO - Health Technol Assess 2001;5(32):1-195
AD - Southampton Health Technology Assessments Centre, Wessex Institute for
Health Research and Development, University of Southampton, UK.
BACKGROUND: The incidence of lung cancer is declining following a drop
in smoking rates, but it is still the leading cause of death from cancer
in England and Wales, with about 30,000 deaths a year. Survival rates
for lung cancer are poor everywhere, but they appear to be better in the
rest of the European Community and the USA than in the UK. Only about 5
per cent of people with lung cancer survive for 5 years, and nearly all
of these are cured by surgery after fortuitously early diagnosis. At
present, only a small proportion of patients (probably about 5 per cent)
with non-small-cell lung cancer are being given chemotherapy. Some
centres treat a greater proportion. OBJECTIVES: This review examines the
clinical effectiveness and cost-effectiveness of four of the newer drugs
- vinorelbine, gemcitabine, paclitaxel and docetaxel - used for treating
the most common type of lung cancer (non-small-cell lung cancer). The
first three drugs are used for first-line treatment, but at present
docetaxel is used only after first-line chemotherapy has failed.
METHODS: This report was based on a systematic literature review and
economic modelling, supplemented by cost data. RESULTS - NUMBER AND
QUALITY OF STUDIES: A reasonable number of randomised trials were found
- three for docetaxel, six for gemcitabine, five for paclitaxel and 13
for vinorelbine. The quality of the trials was variable but good
overall. There was a wide range of comparators. Some trials compared
chemotherapy with best supportive care (BSC), which involves care that
aims to control symptoms, with palliative radiotherapy if needed, but
not to prolong life. Others compared the newer drugs against previous
drugs or combinations. RESULTS - SUMMARY OF BENEFITS: The gains in
duration of survival with the new drugs are modest - a few months - but
worthwhile in a condition for which the untreated survival is only about
5 months. There are also gains in quality of life compared with BSC,
because on balance the side-effects of some forms of chemotherapy have
less effect on quality of life than the effects of uncontrolled spread
of cancer. RESULTS - COSTS: The total cost to the NHS of using these new
drugs in England and Wales might be about GBP 10 million per annum, but
is subject to a number of factors. There would be non-financial
constraints on any increase in chemotherapy for the next few years, such
as staffing; the number of patients choosing to have the newer forms of
chemotherapy is not yet known; and the costs of the drugs may fall, for
example, as generic forms appear. RESULTS - COST PER LIFE-YEAR GAINED:
The available data did not provide an entirely satisfactory basis for
cost-effectiveness calculations. The main problem was the lack of direct
comparisons of the new drugs. In order to strengthen the analysis, three
different modelling approaches were used: pairwise comparisons using
trial data; cost-minimisation analysis, as if all the new regimens were
of equal efficacy; and cost-effectiveness analysis pooling the results
of several trials with different comparators, giving indirect
comparisons of the new drugs by using BSC as the common comparator. A
number of different scenarios were explored through extensive
sensitivity analysis in each model. Outcomes were expressed in
incremental cost per life-year saved or incremental cost, versus BSC.
There was insufficient evidence from which to derive cost per
quality-adjusted life-year. In first-line treatment, vinorelbine,
gemcitabine, and the lower-dose paclitaxel plus cisplatin combinations
generally performed well against BSC under a range of different
scenarios and especially when given as a maximum of 3 cycles.
Incremental cost per life-year gained (LYG) versus BSC varied depending
on scenario, but baseline figures based on trial data and protocols
were: single-agent vinorelbine, pound 2194 per LYG; vinorelbine plus
cisplatin, pound 5206; single-agent gemcitabine, pound 5690; gemcitabine
plus cisplatin, pound 10,041; and paclitaxel plus cisplatin, pound 8537.
In second-line chemotherapy, docetaxel gave a cost per LYG of pound
17,546, again well within the range usually accepted as cost-effective.
However, in routine care, the impact of therapy would be regularly
reviewed, and continuation would depend on response, side-effects,
patient choice and clinical judgement. Chemotherapy would be stopped in
non-responders, making chemotherapy more cost-effective. A 'real-life'
scenario in which 60 per cent of patients receive only 1 or 2 cycles of
chemotherapy gives much lower costs per LYG, with single-agent
gemcitabine, single-agent vinorelbine, and paclitaxel plus platinum
appearing to be cost-saving compared with BSC; the incremental cost of
gemcitabine plus cisplatin would be pound 2478 per LYG, and of
vinorelbine plus cisplatin, pound 2808. At the very least, gains in
duration of survival were achieved without diminution of quality of l
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