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Abramson Cancer CenterNCI CANCERLIT® Search: Chemotherapy for Non-small Cell Lung Cancer - May 2002
National Cancer Institute®
Last Modified: May 1, 2002
Table of Contents
1
UI - 11764664
AU - Nestle U; Hellwig D; Fleckenstein J; Walter K; Ukena D; Rube C; Kirsch
TI -
CM; Baumann M
Comparison of early pulmonary changes in 18FDG-PET and CT after combined
radiochemotherapy for advanced non-small-cell lung cancer: a study in 15
patients.
SO - Front Radiat Ther Oncol 2002;37():26-33
AD - Department of Nuclear Medicine, University Hospital of the Saarland,
Homburg/Saar, Germany. raunes@med-rz.uni-sb.de
2
UI - 11784874
AU - Noda K; Nishiwaki Y; Kawahara M; Negoro S; Sugiura T; Yokoyama A;
TI -
Fukuoka M; Mori K; Watanabe K; Tamura T; Yamamoto S; Saijo N; The Japan
Clinical Oncology Group
Irinotecan plus cisplatin compared with etoposide plus cisplatin for
extensive small-cell lung cancer.
SO - N Engl J Med 2002 Jan 10;346(2):85-91
AD - Kanagawa Cancer Center, Yokohama, Japan.
BACKGROUND: Irinotecan hydrochloride, a topoisomerase I inhibitor, is
effective against small-cell lung cancer. In a phase 2 study of
irinotecan plus cisplatin in patients with extensive small-cell lung
cancer, there was a high response rate and a promising median survival
time. METHODS: We conducted a multicenter, randomized, phase 3 study in
which we compared irinotecan plus cisplatin with etoposide plus
cisplatin in patients with extensive (metastatic) small-cell lung
cancer. RESULTS: The planned size of the study population was 230
patients, but enrollment was terminated early because an interim
analysis found a statistically significant difference in survival
between the patients assigned to receive irinotecan and cisplatin and
those assigned to receive etoposide and cisplatin; as a result, only 154
patients were enrolled. The median survival was 12.8 months in the
irinotecan-plus-cisplatin group and 9.4 months in the
etoposide-plus-cisplatin group (P=0.002 by the unadjusted log-rank
test). At two years, the proportion of patients surviving was 19.5
percent in the irinotecan-plus-cisplatin group and 5.2 percent in the
etoposide-plus-cisplatin group. Severe or life-threatening
myelosuppression was more frequent in the etoposide-plus-cisplatin group
than in the irinotecan-plus-cisplatin group, and severe or
life-threatening diarrhea was more frequent in the
irinotecan-plus-cisplatin group than in the etoposide-plus-cisplatin
group. CONCLUSIONS: Irinotecan plus cisplatin is an effective treatment
for metastatic small-cell lung cancer.
3
UI - 11935300
AU - Vogt U; Zaczek A; Klinke F; Granetzny A; Bielawski K; Falkiewicz B
TI -
p53 Gene status in relation to ex vivo chemosensitivity of non-small
cell lung cancer.
SO - J Cancer Res Clin Oncol 2002 Mar;128(3):141-7
AD - European Laboratory Association Section Ibbenburen, Roggenkampstrasse
10, 49477 Ibbenburen, Germany.
PURPOSE: About 40% of non-small cell lung cancer (NSCLC) patients are
candidates for systemic chemotherapy, despite the fact that at diagnosis
most NSCLC are usually chemoresistant both in vivo and ex vivo. It is
important to develop sufficient methods of prediction of the response to
chemotherapy and to find molecular markers that may prognose this
response. Therefore, a study on the relationship of p53gene status to
the ex vivo chemosensitivity of primary human NSCLC was performed.
METHODS: Three drug combinations (carboplatin/etoposide,
cyclophosphamide/etoposide/epirubicin, and paclitaxel/carboplatin) were
tested in a modified ATP cell viability assay. A group of 28 cases of
primary human NSCLC was assessed. RESULTS: Ex vivo chemosensitivity
testing showed that tumors with p53 mutations were significantly more
resistant to the cyclophosphamide/etoposide/epirubicin regimen than with
normal p53 gene ( P = 0.012). However, no correlation was observed for
two other treatment regimens. CONCLUSION: Mutations in the p53gene can
lead to enhanced chemoresistance, confirming the hypothesis that the p53
gene may serve as a marker of tumor response to treatment in NSCLC.
However, the data also illustrate that some additional factors might
contribute to drug resistance of the examined tumors.
4
UI - 11986422
AU - Ando Y; Figg WD
TI -
Irinotecan in small-cell lung cancer.
SO - N Engl J Med 2002 May 2;346(18):1414-5; discussion 1414-5
5
UI - 11884052
AU - Muller H
TI -
Combined regional and systemic chemotherapy for advanced and inoperable
non-small cell lung cancer.
SO - Eur J Surg Oncol 2002 Mar;28(2):165-71
AD - Department of Oncologic Surgery, Carl von Hess Hospital, Hammelburg,
Germany. H.Mueller@Klinik-Hammelburg.de
AIMS: The objective was to establish the feasibility and toxicity of
regional chemotherapy using an isolated thoracic perfusion (ITP)
technique plus low dose systemic chemotherapy as induction chemotherapy
followed by surgery in advanced non-small cell lung cancer (NSCLC).
METHODS: twenty-two chemotherapy-naive patients with NSCLC (median age
of 57 years, stage III-IV disease with metastases only in the thoracic
region, Karnofsky index >60), received two cycles of regional plus
systemic chemotherapy with a treatment-free interval of 4 weeks. The
cytostatic regimen consisted of 10 mg/m(2) mitomycin, 25 mg/m(2)
navelbine and 30 mg/m(2) cisplatin during ITP followed by low-dose
systemic chemotherapy with 250 mg/m(2) 5-fluorouracil and 20 mg/m(2)
cisplatin given as a continuous infusion on day 1-4. Patients were
re-evaluated for response and surgery was carried out if possible.
RESULTS: All 22 patients could be assessed for toxicity, response and
survival. There were 19/22 remissions corresponding to a regression rate
of 86.4%; 16/22 patients could be resected. This corresponded to a
resectability rate of 72.7% (13 complete resections R0, 1 R1, 2 R2).
Side-effects were transient and acceptable with no treatment- or
surgery-related deaths. Median survival has not been reached after an
observation time of 15 months. The estimated 1-year survival rate was
67.3%. CONCLUSIONS: Regional chemotherapy using an ITP application form
is highly effective in advanced NSCLC stage III-IV leading to a high
rate of resectability with an encouraging survival outcome. Copyright
Harcourt Publishers Limited.
6
UI - 11955727
AU - Bradley JD; Scott CB; Paris KJ; Demas WF; Machtay M; Komaki R; Movsas B;
TI -
Rubin P; Sause WT
A phase III comparison of radiation therapy with or without recombinant
beta-interferon for poor-risk patients with locally advanced
non-small-cell lung cancer (RTOG 93-04).
SO - Int J Radiat Oncol Biol Phys 2002 Apr 1;52(5):1173-9
AD - Radiation Oncology Center, Washington University Medical Center, St.
Louis, MO 63110, USA. bradley@radonc.wustl.edu
PURPOSE: The results of Phase I/II data testing beta-interferon with
radiation therapy in a non-small-cell lung cancer population were
promising. Based on these data, the Radiation Therapy Oncology Group
(RTOG) initiated a Phase III trial to test the efficacy of
beta-interferon in poor-risk patients with Stages IIIA and IIIB
1998, 123 patients were accrued to this trial. Enrolled patients were
not eligible for other chemoradiation studies within the RTOG.
Eligibility criteria included histologically confirmed Stage IIIA or
IIIB non-small-cell lung cancer (according to American Joint Committee
on Cancer) considered clinically inoperable or unresectable at the time
of surgery. Patients were required to have a Karnofsky performance
status 50-70 or >70 and at least 5% weight loss over the preceding 3
months. Betaseron (recombinant human interferon beta(ser),
rHuIFN-beta(ser),) was the chosen preparation of beta-interferon. The
patients randomized to the investigational arm received 16 x 10(6) IU of
Betaseron by i.v. bolus given 3 days a week (Monday-Wednesday) on Weeks
1, 3, and 5. The Betaseron was given 30 minutes before radiation therapy
for a total of nine doses. Irradiation was delivered at 2 Gy per
fraction, 5 days a week, for a total of 60 Gy over 6 weeks and was
identical for both arms. The primary end point of the trial was overall
survival with local control as a secondary end point. Toxicities
occurring within 90 days of therapy completion were defined as acute.
RESULTS: The median follow-up was 4 years (range: 2.5-6 years) for
surviving patients. Seventy-six percent of all patients completed
beta-interferon. Toxicity was the primary reason for noncompliance.
Radiotherapy (RT) compliance was excellent in the RT-alone arm, with 94%
completing therapy, compared to 82% in the beta-interferon arm (p =
0.0475). Grade 3 and 4 acute toxicities were higher on the
beta-interferon arm (p = 0.0249). Grade 3 and 4 acute toxicities were
primarily related to lung (n = 8) and esophagus (n = 7). No Grade 4 or 5
late toxicities were seen for patients in the radiation-alone arm.
However, three patients on the beta-interferon arm experienced Grade 4
toxicity, and one patient died. The 1-year survival rate for the
RT-alone arm was 44% with a median survival time of 9.5 months. The
1-year survival on the beta-interferon arm was 42% with a median
survival of 10.3 months. There was no statistical difference in survival
times (p = 0.66). CONCLUSIONS: This multicenter, controlled Phase III
trial failed to confirm the efficacy of Betaseron in patients receiving
definitive radiotherapy for locally advanced, nonmetastatic
non-small-cell lung cancer. The use of beta-interferon led to greater
rates of both acute and late treatment-related toxicity. The RTOG
continues to investigate other biologic modifiers that may provide a
nontoxic alternative for this poor-risk population.
7
UI - 11784875
AU - Schiller JH; Harrington D; Belani CP; Langer C; Sandler A; Krook J; Zhu
TI -
J; Johnson DH; The Eastern Cooperative Oncology Group
Comparison of four chemotherapy regimens for advanced non-small-cell
lung cancer.
SO - N Engl J Med 2002 Jan 10;346(2):92-8
AD - University of Wisconsin Hospital and Clinics, Madison, USA.
BACKGROUND: We conducted a randomized study to determine whether any of
three chemotherapy regimens was superior to cisplatin and paclitaxel in
patients with advanced non-small-cell lung cancer. METHODS: A total of
1207 patients with advanced non-small-cell lung cancer were randomly
assigned to a reference regimen of cisplatin and paclitaxel or to one of
three experimental regimens: cisplatin and gemcitabine, cisplatin and
docetaxel, or carboplatin and paclitaxel.RESULTS: The response rate for
all 1155 eligible patients was 19 percent, with a median survival of 7.9
months (95 percent confidence interval, 7.3 to 8.5), a 1-year survival
rate of 33 percent (95 percent confidence interval, 30 to 36 percent),
and a 2-year survival rate of 11 percent (95 percent confidence
interval, 8 to 12 percent). The response rate and survival did not
differ significantly between patients assigned to receive cisplatin and
paclitaxel and those assigned to receive any of the three experimental
regimens. Treatment with cisplatin and gemcitabine was associated with a
significantly longer time to the progression of disease than was
treatment with cisplatin and paclitaxel but was more likely to cause
grade 3, 4, or 5 renal toxicity (in 9 percent of patients, vs. 3 percent
of those treated with cisplatin plus paclitaxel). Patients with a
performance status of 2 had a significantly lower rate of survival than
did those with a performance status of 0 or 1. CONCLUSIONS: None of four
chemotherapy regimens offered a significant advantage over the others in
the treatment of advanced non-small-cell lung cancer.
8
UI - 12000824
AU - Locke I; Gillham CM
TI -
Chemotherapy for lung cancer.
SO - N Engl J Med 2002 May 9;346(19):1498; discussion 1498
9
UI - 11989910
AU - Gridelli C; Ferrara C; Del Gaizo F; Guerriero C; Nicolella D; Colantuoni
TI -
G; Rossi A
Chemotherapy of advanced NSCLC in the elderly.
SO - Tumori 2002 Jan-Feb;88(1 Suppl 1):S143-4
AD - Divisione di Oncologia Medica, Azienda Ospedaliera SG Moscati, Avellino.
10
UI - 11989911
AU - Paccagnella A; Oniga F; Favaretto A; Biason R; Ghi MG
TI -
Elderly patients with small cell lung cancer.
SO - Tumori 2002 Jan-Feb;88(1 Suppl 1):S145-7
AD - Oncology Unit, Venice Hospital.
11
UI - 11989921
AU - Repetto L; Pietropaolo M; Granata R; Ventura I; Gianni W
TI -
Weekly paclitaxel infusion in elderly patients with solid tumors.
SO - Tumori 2002 Jan-Feb;88(1 Suppl 1):S39-40
AD - UO Oncologia INRCA, Rome.
12
UI - 11989922
AU - Frontini L
TI -
An interesting antitumor drug in the elderly patients over the age of
70: weekly docetaxel.
SO - Tumori 2002 Jan-Feb;88(1 Suppl 1):S41-3
AD - Divisione di Oncologia Medica, Casa di Cura San Pio X, Milan.
13
UI - 11989933
AU - Puozzo C; Gridelli C; Jaworski M
TI -
Pharmacokinetics of Navelbine oral in elderly patients.
SO - Tumori 2002 Jan-Feb;88(1 Suppl 1):S75-6
AD - Institut de Recherche Pierre Fabre, Boulogne.
14
UI - 11916547
AU - Laack E; Mende T; Durk H; Kneba M; Dickgreber N; Welte T; Muller T;
TI -
Scholtze J; Graeven U; Jasiewicz Y; Edler L; Hossfeld DK
Gemcitabine, vinorelbine and cisplatin combination chemotherapy in
advanced non-small cell lung cancer: a phase II trial.
SO - Eur J Cancer 2002 Mar;38(5):654-60
AD - Department of Oncology and Haematology, University Hospital
Hamburg-Eppendorf, Martinistrasse 52, D-20246 Hamburg, Germany.
laack@uke.uni-hamburg.de
The purpose of this phase II trial was to investigate the efficacy and
safety of a combination chemotherapy with gemcitabine, vinorelbine and
cisplatin in the first-line treatment of advanced non-small cell lung
cancer (NSCLC). Patients with NSCLC stage IIIB or IV disease received
1000 mg/m(2) gemcitabine and 25 mg/m(2) vinorelbine on days 1 and 8 and
1999, 31 patients (21 stage IV and 10 stage IIIB disease), with a median
age of 59 years (range 40-72 years) were enrolled. The overall
intent-to-treat response rate was 45% (95% confidence interval (CI):
27-64%) with 2 complete responders (CR) and 12 partial responders (PR),
7 patients had stable disease and 10 progressed. Median survival was
12.8 months (95% CI: 6.5-12.8+ months), median time to progression was
5.1 months (95% CI: 3.5-7.7 months), and the 1-year survival rate was
52.9% (95% CI: 36.7-76.2%). Patients with stage IIIB disease had a
significantly longer overall survival than patients with stage IV
disease (P=0.05). Transient World Health Organization (WHO) grade IV
leucopenia, anaemia and thrombocytopenia occurred in 3 (10%), 2 (6%) and
3 (10%) patients, respectively. The predominant non-haematological
toxicities were alopecia and nausea/vomiting. 15 patients (48%) had WHO
grade II and III alopecia and 14 patients (45%) nausea/vomiting. The
combination of gemcitabine, vinorelbine and cisplatin has demonstrated
major antitumour efficacy in advanced NSCLC with a manageable toxicity
profile.
15
UI - 11995707
AU - Crino L
TI -
[Role of irinotecan in the treatment of small cell carcinoma]
SO - Tumori 2001 Nov-Dec;87(6):A35-7
16
UI - 11995708
AU - Rinaldi M
TI -
[Second-line and beyond: Docetaxel in the treatment of non-small-cell
lung cancer]
SO - Tumori 2001 Nov-Dec;87(6):A6-9
17
UI - 11742713
AU - Novello S; le Chevalier T
TI -
ALIMTA (pemetrexed disodium, LY231514, MTA): clinical experience in
non-small cell lung cancer.
SO - Lung Cancer 2001 Dec;34 Suppl 4():S107-9
AD - Department of Medicine, Institut Gustave-Roussy, Villejuif, France.
silvia.novello@it.tiscali.com
ALIMTA is a novel, multi-targeted antifolate which inhibits several
enzymes of the folate pathways and it has demonstrated a broad spectrum
of clinical activity in multiple tumor types, including colorectal,
breast, non-small cell lung cancer (NSCLC), pancreatic, head and neck,
bladder and cervical cancers. ALIMTA has been tested in different
patient populations, including those who have received no prior
chemotherapy, those who have relapsed following prior
platinum-containing therapy, and those who have relapsed following prior
chemotherapy without platinum. In every group was demonstrated an
activity comparable to currently used new drugs. ALIMTA was also studied
in association with cisplatin in chemotherapy-naive patients and the
overall response rate is comparable to other current combination
to add vitamin supplementation to reduce toxicity and early indications
are that the frequency of serious toxicities resulting from ALIMTA
treatment has been reduced. On the basis of the results of the studies
reviewed, it is clear that ALIMTA is emerging as a new drug in the
management of NSCLC.
18
UI - 11742714
AU - Momparler RL; Ayoub J
TI -
Potential of 5-aza-2'-deoxycytidine (Decitabine) a potent inhibitor of
DNA methylation for therapy of advanced non-small cell lung cancer.
SO - Lung Cancer 2001 Dec;34 Suppl 4():S111-5
AD - Centre de recherche, Hopital Ste-Justine, Sherbrooke West, 3175 Cote
Ste-Catherine, Montreal, Quebec, Canada. momparlr@ere.umontreal.ca
Although new agents and drug combinations have increased the response
rate in advanced non-small cell lung cancer (NSCLC), long-term survivors
are rare. There is an urgent need to develop new chemotherapeutic
approaches for disease. In a previous pilot phase I-II study on
5-aza-2'-deoxycytidine (5-AZA-CdR) in patients with stage IV NSCLC, we
observed several interesting responses, including one patient that was
still alive (68 months) at the time of publication of our results. In
the present report, we want to point out the long-term follow up of this
patient, who survived 81 months, and discuss the interesting mechanism
of action of 5-AZA-CdR that may have been responsible for this
interesting response. 5-AZA-CdR is a potent inhibitor of DNA
methylation. Recent progress in this field has shown that aberrant
methylation of the promoter region of tumor suppressor genes inhibits
their expression. This epigenetic event can contribute to tumorigenesis.
Since 5-AZA-CdR can reactivate these genes by blocking DNA methylation,
it has the potential to reverse tumorigenesis. This novel mode of action
makes it an interesting agent to investigate for the chemotherapy of
malignant disease, including lung cancer.
19
UI - 11742697
AU - Santo A; Pedersini R; Pasini F; Terzi A; Pari F; Cartei G; Sibau A;
TI -
Molino A; Maiorino A; Panza N; Oletti MV; Maluta S; Calabro F; Cetto GL
A phase II study of induction chemotherapy with gemcitabine (G) and
cisplatin (P) in locally advanced non-small cell lung cancer: interim
analysis.
SO - Lung Cancer 2001 Dec;34 Suppl 4():S15-20
AD - Department of Medical Oncology, University of Verona, Verona, Italy.
antonio.santo@univr.it
BACKGROUND: Gemcitabine-cisplatin (GP) combination is one of the most
active and well tolerated regimens in advanced non-small cell lung
cancer (NSCLC). The aim of this study is to evaluate the activity and
toxicity of the GP regimen as a 21-day schedule in patients (pts) with
2000, 47 pts entered the study: 43 were eligible (40 men and three
women); median age was 61 years (range 45-73); ECOG PS 0-1; histology
was squamous (20 pts), adenocarcinoma (12 pts), large cell (five pts),
and undifferentiated (six pts); stage was IIIAN2 (14 pts, 32.56%), and
IIIB (29 pts, 67.44%). Malignant pleural effusion or superior vena cava
syndrome was criteria of exclusion. Induction treatment consisted of
three cycles of GP (G 1250 mg/m(2) i.v. on days 1 and 8, and P 100
mg/m(2) on day 8 every 3 weeks). Responding and stable pts underwent
surgery (S) and/or radiotherapy (RT). RESULTS: Following a minimum of
two cycles, 39 pts were evaluable for response and 42 for toxicity. Two
pts had complete responses (CR; 5.2%), 24 had partial response (PR;
61.5%), eight had stable disease (SD; 20.5%), and five had progressive
disease (PRO; 12.8%). WHO grades 3 and 4 anaemia, neutropenia and
thrombocytopenia were observed in two, four and two pts, respectively;
non-haematological toxicity was moderate. After induction, stable and
responding pts received either RT (18 pts) or S+RT (13 pts). Among the
16 resected pts, a radical complete resection was possible in 13 cases
(81.3%), whereas tumour down-staging was observed in nine pts (56.2%).
CONCLUSION: GP, as a 3-week neoadjuvant schedule, appears a safe and
active regimen.
20
UI - 11742698
AU - Mattson K; Abratt R; Ten GV; Krofta K; Tonelli D; Avril I
TI -
Docetaxel as neo-adjuvant therapy for radically treatable stage III
non-small cell lung cancer: early results of an international phase III
study.
SO - Lung Cancer 2001 Dec;34 Suppl 4():S21-3
AD - Department of Medicine, Helsinki University Central Hospital, PB 340,
FIN 00029 HUS Helsinki, Finland. karin.mattson@hus.fi
21
UI - 11742699
AU - Rinaldi M; Crino L
TI -
Induction chemotherapy with gemcitabine and cisplatin in stage III
non-small cell lung cancer.
SO - Lung Cancer 2001 Dec;34 Suppl 4():S25-30
AD - Oncologia Medica B, Istituto Regina Elena, Via E. Chianesi 53, 00144
Rome, Italy. mas_rinaldi@yahoo.it
The necessity of improving the long-term survival of patients with
locally advanced non-small cell lung cancer (NSCLC) points out on the
one hand the limit of surgery alone and, on the other hand, the need of
combined modality therapy, in which the role of chemotherapy to control
distant metastases is prominent. Recent experiences support the efficacy
of neoadjuvant chemotherapy with or without radiotherapy. Phase II
studies show response rates of 50-80% and median survival longer than 2
years. Phase III studies suggest that neoadjuvant chemotherapy improves
survival and objective responses, and induces higher percentages of
complete resections compared with surgery alone or chemotherapy and
radiotherapy. The gemcitabine-cisplatin regimen has proved its efficacy
in NSCLC advanced disease with response rate greater than 40% in phase
II and III trials. Representing one of the regimens most used in Europe,
its activity has been investigated also in the neoadjuvant setting.
Phase II studies have reported an average response rate greater than
60%, complete surgical resections in 60-70% of the cases, and 1-year
survival of about 60%. A modern tendency is to use neoadjuvant
chemotherapy in very early stages of NSCLC. Gemcitabine-cisplatin
regimen has been used as a randomised clinical trial (chemotherapy for
early stages trial, CHEST) to compare the efficacy of surgery alone
versus surgery plus preoperative chemotherapy in early-stage disease
(T2-3N0, T1-2N1, T3N1), and to evaluate the progression free survival.
22
UI - 11742695
AU - Galligioni E; Ferro A
TI -
Angiogenesis and antiangiogenic agents in non-small cell lung cancer.
SO - Lung Cancer 2001 Dec;34 Suppl 4():S3-7
AD - Department of Medical Oncology, S. Chiara Hospital, 38100 Trento, Italy.
galligioni@tn.apss.tn.it
Tumour angiogenesis is the result of the imbalance between a large
number of mediators with angiogenic and antiangiogenic activity. It may
be a very early process in vivo and it may follow different pathways in
different organs. Moreover, different roles of angiogenic molecules have
been observed in normal and neoplastic lung and striking differences
between non-small cell lung carcinomas (NSCLC) and SCLC have been
observed. Contradictory results are reported in the literature on the
association of angiogenesis with poor prognosis in NSCLC. Among the
currently available antiangiogenic therapies, the inhibitors of vascular
endothelial growth factor (VEGF), and their receptor (VEGFR) and matrix
metallo-proteinase (MMP), some antivascular agents and the
antiangiogenic scheduling of chemotherapy are beginning to show clinical
efficacy. The best use of the antiangiogenic therapies will probably be
in presence of low tumour burdens and in association with chemotherapy.
However, new surrogate markers of tumour response have to be defined.
23
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35
UI - 11742700
AU - Valerio MR; Russo A; Latteri MA; Modica G; Gulotta G; Armata MG; Bajardi
TI -
E; Cicero G; Pantuso G; Grassi N; Agosta G; Gebbia N
Weekly docetaxel as II line therapy in non-small cell lung cancer: an
interim analysis of a phase II study.
SO - Lung Cancer 2001 Dec;34 Suppl 4():S31-5
AD - Servizio di Chemioterapia, Policlinico Universitario P.Giaccone, Via del
Vespro, 127-90127, Palermo, Italy.
To evaluate the efficacy and toxicity of weekly docetaxel (D) as II line
started a phase II study on advanced (stages IIIB-IV) NSCLC patients
pre-treated with at least one platinum-based chemotherapy regimen with
or without radiotherapy. The schedule consisted of D 40 mg/m(2), weekly
for 6 weeks, followed by a rest period of 2 weeks, for three cycles or
until progression. Eligibility criteria were: histopathologic diagnosis
of NSCLC; age
UI - 11742701
AU - Tumolo S; Toffoli G; Saracchini S; Lo Re G; Bruschi G; Boccieri MG
TI -
Topoisomerase I inhibitors combination chemotherapy in non-small cell
lung cancer.
SO - Lung Cancer 2001 Dec;34 Suppl 4():S37-46
AD - U.O. Oncologia and Pneumologia, AOS-S. Maria degli Angeli, via
Montereale 24, 33170 Pordenone, Italy.
In the last years, the main topoisomerase I inhibitors (TP1-I) (i.e.
topotecan and irinotecan) have been used in combination chemotherapy in
non-small cell lung cancer. Several drugs (also alternative to
cisplatin) have been used in combination with TP1-I, but to date the
higher remission rate obtained with combinations is not translated into
a more prolonged survival in comparison with TP1-I given alone. On the
other hand, the toxicity of TP1-I combinations is greater than those of
TP1-I used alone. The superior efficacy of combinations versus TP1-I
used alone remains an open question. Furthermore, the best schedule for
TP1-I has not been completely elucidated. Randomised studies are few
(only two phase III trials) and only controlled studies will be able to
clarify the best TP1-I combination regimen.
UI - 11742702
AU - Georgoulias V; Samonis G; Papadakis E; Alexopoulos A; Tsiafaki X; Rapti
TI -
A; Veslemes M; Grigoratou T; Palamidas P; Kouroussis C; Mavroudis D;
Kakolyris S; Giannakakis T; Vlachonikolis J; Greek Cooperative Group for
Lung Cancer
Comparison of docetaxel/cisplatin to docetaxel/gemcitabine as first-line
treatment of advanced non-small cell lung cancer: early results of a
randomized trial.
SO - Lung Cancer 2001 Dec;34 Suppl 4():S47-51
AD - University Hospital of Heraklion, Crete, Greece.
The study compares docetaxel plus cisplatin (DC) and docetaxel plus
gemcitabine (DG) regimens for the treatment of advanced non-small cell
lung cancer (NSCLC). Patients were randomized to receive either the DC
or the DG combination. They were stratified according to age,
performance status (PS) and stage of disease. Three hundred seventeen
patients entered the study. Of them, 162 received the DC regimen and 155
the DG regimen. There were no differences in the patients'
characteristics between the two study arms. Preliminary analysis
included 132 evaluable patients in the DC arm and 114 in the DG arm.
Three complete responses (CR) (2.3%) and 39 partial responses (PR) (30%)
were documented in the DC arm (response rate (RR) 32.3%; 95% CI
23.87-39.76%), whereas 1 CR (0.9%) and 38 PR (33%) were documented in
the DG arm (RR: 33.9%; 95% CI 25.5-42.92%). No differences in the RR,
response duration, time to tumor progression, overall survival and
1-year survival were observed between the two groups. Regarding
toxicity, there were no significant differences in grade 3-4 anaemia and
thrombocytopenia between the two arms. However, grade 3-4 neutropenia
occurred in 40 patients (33%) treated with the DC regimen and in 31
patients (22%) treated with the DG regimen (P=0.01). Twenty-four (16%)
patients in the DC arm and 20 (14%) in the DG arm developed febrile
neutropenia. There was one death due to sepsis in each arm.
Non-haematological toxicity was mild and equal in the two arms, with the
exception of grade 3-4 nausea and diarrhoea, which were more frequent in
the DC arm. In conclusion, preliminary results showed that the DG
regimen was as effective as the DC regimen. The toxicity profile of the
DG combination was relatively milder. Hence, cisplatin cannot be
considered longer as a mandatory component of chemotherapy against
NSCLC.
UI - 11742703
AU - Greco FA
TI -
Paclitaxel-based combination chemotherapy in advanced non-small cell
lung cancer.
SO - Lung Cancer 2001 Dec;34 Suppl 4():S53-6
AD - The Sarah Cannon Cancer Center, 250 25th Av. North, Suite 412,
Nashville, TN 37203, USA.
Paclitaxel has proven to be a useful drug for patients with advanced
non-small cell lung cancer (NSCLC). Paclitaxel-based combination
chemotherapy, particularly with carboplatin, has become a very popular
combination in the US. This article will review the conclusions of
several studies regarding paclitaxel-based chemotherapy. The data
provide evidence that this therapy produces good palliation and
prolongation of survival for patients with NSCLC and is superior to
older cisplatin-based chemotherapy. These results in patients with
advanced disease have important implications for neoadjuvant and/or
adjuvant approaches in patients with lower stages of disease, and
several studies are ongoing.
UI - 11742704
AU - Pronzato P; Vigani A; Tognoni A; Vaira F; Canessa P
TI -
Anthracyclines in non-small cell lung cancer.
SO - Lung Cancer 2001 Dec;34 Suppl 4():S57-9
AD - Department of Medical Oncology, Ospedale S. Andrea, 19100 La Spezia,
Italy. ppronza@tin.it
The literature concerning the use of anthracyclines in the treatment of
non-small cell lung cancer (NSCLC) is reviewed here. Overall, the
activity of doxorubicin (DOXO) is unsatisfactory, whereas, the analogous
epidoxorubicin (EPI) yields a 30% response rate (RR) when administered
at intermediate-high doses. All active drugs, including EPI, should be
considered to design the most active combination. Mainly, in the
setting, in which an objective response is very important, for instance
the neo-adjuvant pre-operatory setting.
UI - 11742705
AU - Van Putten JW
TI -
Activity of the combination of high-dose epirubicin with gemcitabine in
advanced non-small-cell lung cancer.
SO - Lung Cancer 2001 Dec;34 Suppl 4():S61-4
AD - Department of Pulmonary Diseases, University Hospital, Hanzeplein 1,
9713 GZ Groningen, The Netherlands. j.w.g.van.putten@int.azg.nl
UI - 11742706
AU - Frasci G; Lorusso V; Panza N; Comella P; Nicolella G; Bianco A;
TI -
DeCataldis G; Belli M; Iannelli N; Massidda B; Mascia V; Comella G; De
Lena M
Gemcitabine plus vinorelbine yields better survival outcome than
vinorelbine alone in elderly patients with advanced non-small cell lung
cancer. A Southern Italy Cooperative Oncology Group (SICOG) phase III
trial.
SO - Lung Cancer 2001 Dec;34 Suppl 4():S65-9
AD - Division of Medical Oncology, National Turnor Institute, Via M Semmola
80131, Naples, Italy. gifrasci@sirio-oncology.it
OBJECTIVE: This phase III study was aimed at evaluating whether the
addition of gemcitabine (G) to vinorelbine (V) could improve the
survival and quality of life (QoL) of elderly patients with advanced
NSCLC. PATIENTS AND METHODS: Patients with advanced NSCLC, aged >or=70
years, were randomly allocated to receive V 30 mg/m(2) on days 1 and 8
every 3 weeks or G 1200 mg/m(2) plus V 30 mg/m(2) on days 1 and 8 every
3 weeks. Survival was the main end point of the study. The estimated
sample size was 120 patients per arm, but an interim analysis of
survival was planned on the first 60 patients per arm. RESULTS: In May
1999, an interim analysis was performed with the survival data of the
first 120 eligible patients (V(arm)=60, G+V(arm)=60). Forty-nine
patients had stage IIIB disease and 71 patients stage IV disease, median
potential follow-up of 14 months (range; 3-22), 93 patients had died
(G+V(arm)=41, V(arm)=52). Median survival time (MST) was 29 weeks and
projected 1-year survival was 30% in the G+V(arm); these values were 18
weeks and 13% in the V(arm). At multivariate Cox analysis, the risk of
death in the G+V(arm) compared with V(arm) was 0.48 (95% C1=0.29-0.79;
P<0.01). Combination therapy was also associated with a clear delay in
symptom and QoL deterioration. The ORR was 22 and 15% in the G+V and
V(arms), respectively. Toxicity was not irrelevant in both arms.
CONCLUSIONS: G+V treatment is associated with a significantly better
survival than V alone in elderly NSCLC patients. The magnitude of the
difference justifies the early closure of the study. The G+V regimen is
now the SICOG reference regimen in this type of patients.
UI - 11742707
AU - Kakolyris S; Kouroussis C; Souglakos J; Agelaki S; Kalbakis K; Vardakis
TI -
N; Vamvakas L; Georgoulias V
Cisplatin and irinotecan (CPT-11) as second-line treatment in patients
with advanced non-small cell lung cancer.
SO - Lung Cancer 2001 Dec;34 Suppl 4():S71-6
AD - Department of Medical Oncology, School of Medicine, University General
Hospital of Heraklion, PO Box 1352, 71110 Heraklion, Crete, Greece.
georgoul@med.uch.gr
Irinotecan (CPT-11) and cisplatin (P) are both active agents against
non-small cell lung cancer (NSCLC), and their combination has shown in
vitro an additive or synergistic effect. We conducted a phase II study
to determine the toxicity and efficacy of their combination as salvage
treatment in patients with advanced NSCLC progressing after a
docetaxel-based front line regimen. Forty-four patients with
histologically confirmed NSCLC were enrolled. The patients' median age
was 60.5 years; 39 patients (87%) were male; 38 (86%) had stage IV
disease; and 32 (73%) had a performance status (WHO) 0-1. CPT-11 was
administered as a 60 min i.v. infusion at a dose of 100 mg/m(2) on day 1
and 110 mg/m(2) on day 8; P was administered at a dose of 80 mg/m(2) on
day 8 after CPT-11 administration. Treatment was repeated every 3 weeks.
A total of 159 chemotherapy cycles was administered. In an
intention-to-treat analysis, nine patients (22; 95% CI: 9.28-34.62%)
achieved a partial response (PR), 8 (20%) had stable disease (SD), and
24 (58%) progressive disease (PD). The median duration of response was 4
months, the median time-to-progression (TTP) 8 months, and the median
survival for the entire group 8 months. Grade 3-4 neutropenia was
observed in 20 (46%) patients and in four cases this was febrile,
requiring patient's hospitalisation. Grade 3-4 thrombocytopenia occurred
in four (9%) patients. Grade 3-4 diarrhoea was seen in 12 (27%) patients
and three of them required hospitalisation. Grade 2-3 neurotoxicity was
observed in two (4%) patients and grade 2-3 fatigue in 14 (32%). Other
toxicity was mild and no treatment-related death was reported. The
combination of CPT-11 and P is a safe, well-tolerated, and active
regimen for the treatment of patients with advanced NSCLC previously
treated with a docetaxel-based front-line regimen.
UI - 11742708
AU - Agelaki S; Bania H; Kouroussis C; Blazoyiannakis G; Souglakos J;
TI -
Tsiafaki X; Kalbakis K; Rapti A; Androulakis N; Georgoulias V; Papadakis
E
Second-line treatment with vinorelbine and carboplatin in patients with
advanced non-small cell lung cancer. A multicenter phase II study.
SO - Lung Cancer 2001 Dec;34 Suppl 4():S77-80
AD - Department of Medical Oncology, University General Hospital of
Heraklion, PO Box 1352, Heraklion 71110, Crete, Greece.
georgsec@med.uch.gr
OBJECTIVE: A phase II study was conducted to evaluate the efficacy and
toxicity of vinorelbine-carboplatin (VNB-C) combination as a salvage
treatment in patients with advanced non-small cell lung cancer (NSCLC)
progressing after or failing previous non-platinum, taxane-based
treatment. PATIENTS AND METHODS: Thirty-seven patients with
cytologically or histologically confirmed NSCLC were enrolled. VNB 30
mg/m(2) was administered on days 1 and 8 and C 300 mg/m(2) on day 1
every 28 days. G-CSF (5 microg/kg per day s.c.) was used
prophylactically on days 10-15 in case of grade 3-4 neutropenia or
febrile neutropenia after the first cycle. RESULTS: Twenty-nine patients
were evaluable for response and all were evaluable for toxicity. In an
intention-to-treat analysis, two (5%) complete and four (11%) partial
responses were documented for an overall response rate of 16% (95% CI,
4.49-28.84%). Eleven (30%) patients experienced disease stabilisation
and 20 (54%) disease progression. The median duration of response was
7.5 months, the median TTP was 9 months, and the median survival was 8.5
months. Patients with objective remission and stable disease had a
statistically significant survival benefit over patients with disease
progression. Grade 3 and 4 neutropenia occurred in three (8%) and ten
(27%) patients, respectively, and six cases (16%) were complicated with
fever. Grade 4 thrombocytopenia was documented in one (3%) patient.
Non-hematological toxicity was mild, with grade 2 and 3 asthenia
reported in 18 (48%) patients. No treatment-related deaths occurred.
CONCLUSION: VNB-C combination is well tolerated and retains a notable
degree of activity in NSCLC patients progressing after previous
non-platinum, taxane-based treatment. Moreover, it confers tumour growth
control in a significant proportion of patients, and this seems to be
associated with a survival benefit for them.
UI - 11742709
AU - Caffo O
TI -
Radiosensitization with chemotherapeutic agents.
SO - Lung Cancer 2001 Dec;34 Suppl 4():S81-90
AD - Department of Medical Oncology, Santa Chiara Hospital, 38100 Trento,
Italy. caffo@tn.apss.tn.it
The combination of low-dose chemotherapy and thoracic radiotherapy is
one of the treatments proposed in an attempt to improve the prognosis of
locally advanced non-small cell lung cancer. Chemotherapeutic drugs
administered at subtoxic doses act by means of a radiosensitization
mechanism. Platinum-derived drugs have been historically used as
radiosensitizers, without cumulative unacceptable toxicity. Many new
chemotherapeutic agents, which have shown promising results in terms of
disease control in advanced non-small cell lung cancer, show also a
radiosensitizing activity. However, the optimal dose and timing of such
drugs when used concurrently to radiotherapy are unknown. This paper
will review the results obtained using new chemotherapeutic drugs as
radiosensitizers.
UI - 11742696
AU - Novello S; le Chevalier T
TI -
Is there a standard strategy in the management of locally advanced
non-small cell lung cancer?
SO - Lung Cancer 2001 Dec;34 Suppl 4():S9-14
AD - Departement of Medicine, Institut Gustave-Roussy, Villejuif, France.
Lung cancer is the leading cause of cancer mortality in the United
States for both men and women. Twenty to thirty percent of patients with
non-small cell lung cancer (NSCLC) present with locally advanced,
unresectable tumors. While small improvements in outcome have occurred
for this group of patients in the last decade, 5-year survival remains
low, ranging from 5 to 20%. Distant metastases and loco-regional
progression remain significant patterns of failure. Up to the late
1980s, the standard management was conventional thoracic radiotherapy
for locally advanced NSCLC, but when treated with radiotherapy alone,
less than 10% of patients survived for 5 years or more. Sixty to seventy
percent failed at distant sites and less than 20% achieved durable local
control. The addition of chemotherapy reduces the rate of distant
failure, improves survival and the combination of chemotherapy and
radiotherapy has become the standard of care of patients with locally
advanced NSCLC. Current developments aim to optimise individual
components of combined modality schedules, increase their synergism and
minimise toxicity.
UI - 11742711
AU - Klastersky J; Paesmans M
TI -
Response to chemotherapy, quality of life benefits and survival in
advanced non-small cell lung cancer: review of literature results.
SO - Lung Cancer 2001 Dec;34 Suppl 4():S95-101
AD - Department of Medicine, Institut Jules Bordet, Rue Heger-Bordet 1, B
1000, Brussels, Belgium. jean.klastersky@bordet.be
The survival benefit obtained with chemotherapy administration in
advanced non-small cell lung cancer (NSCLC) patients has been
demonstrated by numerous meta-analyses published between 1993 and 1999
on randomised trials comparing best supportive care with or without
chemotherapy. However, some clinicians are still reluctant to prescribe
chemotherapy in these patients, arguing that the benefit is too small to
counterbalance the side effects. The goal of this paper is to review the
reasons favouring the administration of chemotherapy. First, there is a
demonstrated relationship between response to chemotherapy and survival,
although more data are needed to assess response to chemotherapy as a
surrogate for survival. Secondly, recent randomised trials comparing
best supportive care to chemotherapy, but not included in the
meta-analyses, have successfully incorporated quality of life (QoL) as
an endpoint, sometimes as a primary endpoint. The survival benefit shown
by the meta-analyses is confirmed by these latter trials; in addition,
the QoL assessments, despite some methodological problems inherent to
attrition in these poor prognosis patients, also favour chemotherapy
with regard to some global aspects, such as physical, functioning,
emotional, cognitive or social components, as well as some lung cancer
symptoms. We conclude that there are no longer convincing arguments
against chemotherapy administration in patients with advanced NSCLC, at
least in patients eligible for inclusion in clinical trials.
UI - 11914903
AU - Sadava D; Ahn J; Zhan M; Pang ML; Ding J; Kane SE
TI -
Effects of four Chinese herbal extracts on drug-sensitive and
multidrug-resistant small-cell lung carcinoma cells.
SO - Cancer Chemother Pharmacol 2002 Apr;49(4):261-6
AD - Division of Molecular Medicine, City of Hope Medical Center, 1500 E.
Duarte Rd., Duarte, CA 91010, USA. dsadava@jsd.claremont.edu
PURPOSE: We examined the pharmacology, cell biology and molecular
biology of small-cell lung carcinoma cells treated with four extracts of
Chinese herbal medicines. Many cancer patients take these medicines, but
their effects at the cellular level are largely unknown. We were
especially interested in the effects on drug-resistant cells, as
resistance is a significant clinical problem in lung cancer. METHODS:
Drug-sensitive (H69), multidrug-resistant (H69VP) and normal lung
epithelial cells (BEAS-2) were exposed to extracts from two plants used
in Chinese herbal medicine for lung cancer: Glycorrhiza glabra (GLYC)
and Olenandria diffusa (OLEN), and to extracts of two commercially
available combinations of Chinese herbal medicines, SPES (15 herbs) and
PC-SPES (8 herbs). Cytotoxicity was measured in terms of cell growth
inhibition (IC(50)). The kinetics of DNA fragmentation after exposure to
the herbal extracts was measured by BudR labeling followed by ELISA.
Apoptosis was measured by the TUNEL assay followed by flow cytometry.
Expression of apoptosis- and cell cycle-related genes was measured by
reverse transcription of mRNA followed by filter hybridization to arrays
of probes and detection by chemiluminescence. RESULTS: In each case, the
four herbal extracts were equally cytotoxic to H69 and H69VP and less
cytotoxic to BEAS-2. All four extracts induced DNA fragment
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