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Abramson Cancer Center
NCI CANCERLIT® Search: Chemotherapy for Non-small Cell Lung Cancer - February 2002
National Cancer Institute®
Last Modified: February 1, 2002
Table of Contents
1
UI - 11521802
AU - Quoix E; Breton JL; Daniel C; Jacoulet P; Debieuvre D; Paillot N;
TI -
Kessler R; Moreau L; Coetmeur D; Lemarie E; Milleron B
Etoposide phosphate with carboplatin in the treatment of elderly
patients with small-cell lung cancer: a phase II study.
SO - Ann Oncol 2001 Jul;12(7):957-62
AD - Pulmonology Unit, University Hospital, Strasbourg, France.
Elisabeth.Quoix@chru-strasbourg.fr
BACKGROUND: Although the average age of lung cancer patients is
increasing, many elderly patients remain undertreated, mainly because of
the fear of higher treatment toxicity in this category of patients. We
conducted a study to evaluate the efficacy and tolerability of a
combination therapy with carboplatin (C) and etoposide phosphate (EP) in
elderly patients with Small-Cell Lung Cancer (SCLC). PATIENTS AND
METHODS: Previously untreated patients older than 70 years with stage
IIIB/IV SCLC received a combination of EP (100 mg/m2 D1, D2, D3) and C
(D1, dose calculated according to the Calvert formula). Response rate,
survival and toxicity were assessed. RESULTS: Thirty-eight patients
(mean age 76 years, range 70-88 years) received a total of 162 cycles.
Eighteen patients (47%) received the six scheduled cycles. Thirty
patients were evaluable for efficacy (2 CR and 20 PR). The median
survival was 237 days and the one-year probability of survival was 26%.
The most common adverse effect was transient grade 3 or 4 neutropenia,
observed during 57% of evaluable cycles, while five episodes of febrile
neutropenia also occurred, with one fatal (bacteremia). It is noteworthy
that no renal or liver toxicity was observed, and no mucitis was noted.
Unfortunately, a relatively high proportion of patients died shortly
after the start of the study. Although most deaths seemed unrelated to
the treatment, the possibility of its exacerbatory effect on
comorbidities, especially cardiovascular, cannot be excluded.
CONCLUSION: The two-drug regimen of carboplatin and etoposide phosphate
is feasible in most elderly patients with an acceptable toxicity, and
the overall results suggest that patients even older than 70 years may
benefit from full treatment. Therefore, consideration should be given to
offering active treatment to most patients with SCLC, regardless of age
but with special attention paid to comorbidities.
2
UI - 11720756
AU - van Zandwijk N
TI -
Neoadjuvant strategies for non-small cell lung cancer.
SO - Lung Cancer 2001 Dec;34 Suppl 2():S145-50
AD - Department of Thoracic Oncology, The Netherlands Cancer Institute,
Plesmanlann 121, 1066 CX, Amsterdam, The Netherlands. zandwijk@nki.nl
During the last 15-20 years, several phase II trials have investigated
the use of chemotherapy and chemoradiation prior to surgery in the
management of stage IIIA non-small cell lung cancer (NSCLC). The results
of these studies, in contrast to insignificant outcomes of comparative
studies with chemotherapy in the postoperative setting, have been
encouraging. Moreover, phase III trials comparing surgery alone with
chemotherapy plus surgery have confirmed the efficacy of this
multimodality approach. In recent years, newer and more effective
chemotherapy combinations have become available and are now being used
prior to surgery. One focus of ongoing research is to confirm that
preoperative chemotherapy followed by complete resection is a better
treatment approach than surgery alone, even for patients with
early-stage NSCLC. Recent data suggest that induction chemotherapy in
this category of patients yields high response rates and does not
compromise the outcome of surgery. Given the systemic nature of lung
cancer it is estimated that systemic therapy before local treatment will
play an increasingly important role for patients with early-stage NSCLC.
3
UI - 11720757
AU - Jablonka S; Furmanik F; Jablonka A; Paprota K; Karczmarek-Borowska B;
TI -
Kukielka-Budny B; Korobowicz E; Zdunek M; Sagan D
Principles of induction chemotherapy for non-small cell lung cancer.
SO - Lung Cancer 2001 Dec;34 Suppl 2():S151-3
AD - Department of Thoracic Surgery, University School of Medicine,
Jaczewskiego 8, 20-954, Lublin, Poland.
The results of lung cancer treatment have not significantly improved for
many years. About 35% of patients with non-small cell lung cancer
(NSCLC) are in clinical stage IIIA. Clinically asymptomatic distant
metastases occur in the majority of these patients. In such cases only
combined treatment offers a chance of cure. In the Chest Surgery Center
in Lublin a clinical trial was carried out aimed to assess late results
of combined treatment in patients with IIIA NSCLC. Over 700 patients
were enrolled in the study. The results of the trial disclosed, that
neoadjuvant chemotherapy prolonged life of the operated patients and
improved their life quality. However, a question of qualification for
this complex treatment and complexity of assessment criteria, still
remain to be answered.
4
UI - 11720759
AU - Krzakowski M
TI -
New agents within the preoperative chemotherapy of non-small cell lung
cancer.
SO - Lung Cancer 2001 Dec;34 Suppl 2():S159-63
AD - Lung and Thoracic Tumors Department, The M. Sklodowska-Curie Cancer
Center and Institute of Oncology, 5 K.W. Roentgen St., 02-781, Warsaw,
Poland. maciekk@coi.waw.pl
Surgery alone fails to cure the majority of resected non-small cell lung
cancer (NSCLC) patients. Only about half of stage I and II patients
remain free of the disease for 5 and more years. The vast majority of
stage IIIA patients resected for cure relapse (most of them develop
distant spread). A combined modality approach (preoperative
cisplatin-based chemotherapy, surgery and radiotherapy) has been shown
to increase cure rates in stage IIIA NSCLC from 10-15% to 25-40%. Future
improvements, currently under investigation, are expected with the use
of chemotherapy prior to surgery in resectable patients with stage IB
and II disease. The advent of newer agents, such as paclitaxel,
docetaxel, vinorelbine, and gemcitabine have led to the design of
potentially more effective preoperative regimens with the ability to
advance the cure rate even further. The superiority of new cytotoxic
agents incorporated into the preoperative systemic therapy has not been
definitely confirmed. This overview presents the current experience with
the use of new agents in preoperative chemotherapy for NSCLC.
5
UI - 11720760
AU - Manegold C
TI -
Chemotherapy for advanced non-small cell lung cancer: standards.
SO - Lung Cancer 2001 Dec;34 Suppl 2():S165-70
AD - Department of Internal Medicine/Medical Oncology,
Thoraxklinik-Heidelberg, Amalienstr. 5, D-69126, Heidelberg, Germany.
prof.manegold@t-online.de
For non-small cell lung Cancer (NSCLC) patients in good clinical
condition (PS 0-1), Platin-based combination chemotherapy is currently
recommended to prolong survival, prevent or reduce tumor-related
symptoms, and maintain the quality of life. Nonetheless, the clinical
availability of newer cytotoxic drugs has considerably increased the
chemotherapeutic options for Platin-based chemotherapy and, at the same
time, increased the difficulties in choosing the most appropriate
regimen. These difficulties became especially clear when oncologists
were confronted with the disappointing results from ECOG 1594, a study
which tested four popular Platin-based combinations. Since no survival
advantages could be shown by any of the four combinations used in ECOG
1594, one of the pertinent question seems to be whether, and in what
form, a Platin-free combination regimen with newer agents should replace
the currently recommended Platin-based therapy? A strong indication that
non-Platin-containing regimens are not inferior came from at least two
randomized trials. However, first results from EORTC 08975 -trial, did
not confirm these observations, since the trend seems to be towards
better results for the patients on Platin-containing regimens. A number
of trials have shown that patients with PS >1 do not benefit from
combination regimens. For these and for elderly patients, single agent
therapy with newer cytotoxic agents may be for various reasons an
attractive chemotherapeutic alternative for palliation. Several
cooperative studies have proven that single agent therapy is superior to
best supportive care. Vinorelbine was the first new agent tested in
randomized, controlled trials in the elderly population, and was found
to give statistically significant survival advantages in comparison to
best supportive care only. As chemotherapy gains wider acceptance for
advanced and early stage NSCLC, the need for an effective second-line
chemotherapy is also growing. On the basis of two randomized, phase III
studies, Docetaxel has recently become the first cytotoxic agent to be
registered for second-line therapy in NSCLC. Both studies demonstrated
that Docetaxel 75 mg/m2 given every 3 weeks significantly prolongs
survival, and offers clinically meaningful benefits to patients who have
an acceptable performance status.
6
UI - 11720761
AU - Thatcher N
TI -
Chemotherapy for advanced non-small cell lung cancer.
SO - Lung Cancer 2001 Dec;34 Suppl 2():S171-5
AD - Christie and Wythenshawe Hospitals, Wilmslow Road, M20 4BX, Manchester,
UK. linda.aschcroft@christie-tr.nwest.nhs.uk
Chemotherapy for advanced NSCLC in good performance status has survival
benefit, reduces tumour symptoms and can improve quality of life. Future
challenges include defining the optimal chemotherapy and incorporating
the newer agents to improve patients' outcome. In particular treatment
of the elderly and patients with poorer performance status need to be
developed with more attention being paid to relief of symptoms and
minimising treatment toxicity.
7
UI - 11720763
AU - Jassem J
TI -
Combined modality treatment with chemotherapy and radiation in locally
advanced non-small cell lung cancer.
SO - Lung Cancer 2001 Dec;34 Suppl 2():S181-3
AD - Department of Oncology and Radiotherapy, Medical University of Gdansk, 7
Debinki St., 80-211, Gdansk, Poland. jjassem@amg.gda.pl
This article reviews combined chemotherapy and radiation in locally
advanced inoperable non-small cell lung cancer. Presented are rationale
for the use of this strategy, methods of combining drugs and radiation
and results of major phase III trials.
8
UI - 11720748
AU - Monzo M; Rosell R; Taron M
TI -
Drug resistance in non-small cell lung cancer.
SO - Lung Cancer 2001 Dec;34 Suppl 2():S91-4
AD - Medical Oncology Service, Hospital Germans Trias i Pujol, Crta Canyet,
s/n, 08916 , Badalona, Barcelona, Spain.
There is an underlying feeling in the oncology community that
chemotherapy has reached a therapeutic glass ceiling in non-small cell
lung cancer (NSCLC) and that we will never attain the acceptable
survival rates that are just beyond our reach. Multiple clinical trials
have tested doublets, triplets and sequential chemotherapy in what is
often regarded as a futile attempt to break through this ceiling. Recent
large randomized trials have not demonstrated that any of these
combinations is superior to any of the others. Nevertheless, the
analysis of DNA or RNA from patients can permit us to assess genes that
may be specific targets of certain cytotoxic agents and others that may
be markers of multidrug resistance. With this in mind, the Spanish Lung
Cancer Group has designed a trial to test the involvement of various
genes in resistance to gemcitabine and cisplatin.
9
UI - 11776616
AU - Wang J; Liu X; Wu M
TI -
[Expression and reversion of drug resistance- and apoptosis-related
genes of a DDP-resistant lung adenocarcinoma cell line A549DDP]
SO - Zhonghua Zhong Liu Za Zhi 1999 Nov;21(6):422-6
AD - Department of Internal Medicine, School of Oncology, Beijing Medical
University, Beijing 100036.
OBJECTIVE: To study the expression of drug resistance- and
apoptosis-related genes of A549DDP cells as compared to the parental
cell line A549, and its reversion by antisense s-oligodeoxynucleotide
(S-ODN) of the differentially expressed genes. METHODS: Sense and
antisense S-ODN were transferred into A549DDP cells by lipofectin.
Expression of genes related to drug resistance and apoptosis was
examined by RT-PCR, immunocytochemistry and flow cytometry. Apoptosis
was identified by DNA electrophoresis and TUNEL, and cell growth by MTT
uptake. RESULTS: The expression of bcl-2 was positive and that of MRP at
mRNA and protein levels was increased in A549DDP cells compared to A549
cells. MDR1, c-myc and TOPO II were similarly expressed in the two cell
lines. Both cell lines were negative for c-erbB-2 expression. In A549DDP
cells, the expression of bcl-2 and MRP was significantly inhibited by
respective antisense S-ODN. Antisense S-ODN could also significantly
inhibit proliferation of A549DDP cells, and promote cell apoptosis by
reducing its resistance to cisplatin. CONCLUSION: Bcl-2 and MRP genes
are responsible for the induced resistance of A549DDP cells to
cisplatin.
10
UI - 11556248
AU - Le Chevalier T
TI -
Eve of the third millennium, providing an update on the management of
non-small cell lung cancer (NSCLC).
SO - Anticancer Drugs 2001 Jul;12 Suppl 3():S1
11
UI - 11556249
AU - Van Zandwijk N
TI -
[Therapeutic strategies in neoadjuvant therapy of non-small cell lung
cancer: benefits of gemcitabine]
SO - Anticancer Drugs 2001 Jul;12 Suppl 3():S15-9
AD - Departement d'Oncologie Thoracique, Netherlands Cancer Institute, 1066
CX Amsterdam, Pays Bas. zandwijk@nki.nl
Stages of non-small cell lung cancer (NSCLC) that are potential
candidates for surgical resection have been treated in several ways:
surgery alone is curative in only two-thirds of cases and post-operative
radiotherapy (RT) provides only weak control of advanced-stage disease.
Since metastatic recurrence is due to the presence of micrometastases,
chemotherapy (CT) can be envisaged, even at an early stage of the
disease--first with the CT/RT induction combination, which improves
survival (median survival: 15 months) and the resection rate (70%).
Recent studies on neoadjuvant therapy have evaluated the usefulness of
different induction CT regimens. Among these, the gemcitabine/cisplatin
study protocol (GC), set up in a phase II study for patients with stage
IIIA N2 NSCLC, was very effective [objective response (OR): 70.2%;
median survival: 19 months] and should be promising for stages IB and
II. Other studies involving platinum analogs have shown good OR rates
inducing a high resection rate and a reduction in the spread to
mediastinal lymph nodes. Major studies are ongoing, one of which
compares GC + surgery versus surgery alone (stages IB-IIIA); the other
regimen aims to evaluate GC versus paclitaxel/carboplatin as well as two
induction strategies.
12
UI - 11556250
AU - Le Chevallier T
TI -
[Multi-targeted antifolate therapy roe non-small cell lung cancer and
mesothelioma]
SO - Anticancer Drugs 2001 Jul;12 Suppl 3():S21-T5
AD - Institut Gustave Roussy, 94800 Villejuif, France. tle-che@igr.fr
Multi-targeted antifolate (MTA) is an anti-metabolite with useful
activity in the treatment of non-operable patients presenting with
non-small cell lung cancer. Its good efficacy and tolerability profile
as first-line therapy was demonstrated in phase II studies of MTA as
monotherapy. The use of MTA as second-line therapy with or without a
platinum analog also provides good results. It should be observed that,
in combination with cisplatin (C), docetaxel or gemcitabine (G), MTA
presents synergistic efficacy: two phase II protocols have shown that
the MTA/C combination as first-line therapy presented high efficacy
(objective response: 39-45%) and low toxicity. These results are
promising and also seem to be observed in an ongoing phase II study
evaluating MTA/G. In the treatment of mesothelioma, promising activity
was observed for the MTA/C combination, and this activity is under
evaluation in ongoing phase II and phase III studies.
13
UI - 11556251
AU - Bunn PA
TI -
[State-of-the art treatment of locally advanced and metastatic non-small
cell lung cancer]
SO - Anticancer Drugs 2001 Jul;12 Suppl 3():S3-8
AD - University of Colorado Cancer Center, Denver, CO 80220-3706, USA.
paul.bunn@uchsc.edu
Despite the poor mortality figures from lung cancer, advances have been
observed in the treatment of advanced (stages IIIB and IV) non-small
cell lung cancer (NSCLC). In the first instance, such advances have been
achieved thanks to chemotherapy (CT) consisting of platinum-based
compounds (results demonstrated in several phase III studies) and then
thanks to newer cytotoxic agents such as gemcitabine. Used as
monotherapy, gemcitabine provides a marked benefit compared to the
standard treatment consisting of etoposide/cisplatin (EC) (21% objective
response, 39% survival at 1 year). A good efficacy profile of this agent
in combination with platinum analogs was also observed in randomized
phase III studies, confirming the significant higher survival obtained
with the gemcitabine/cisplatin (GC) combination (in GC versus C
protocols and that comparing four doublets of CT). Results observed with
G without platinum analogs are comparable to those of treatment with a
platinum agent. Other studies conducted with triplets of CT need to be
confirmed. Newer non-cytotoxic agents have also been studied: the
anti-vascular endothelial growth factor monoclonal antibody with or
without CT may prolong survival; docetaxel improves overall survival
outcomes compared to palliative therapy. In locally advanced stages,
advances have been made possible by radiochemotherapy (RT/CT): several
phase II and phase III studies using EC and RT have been conducted.
Lastly, in induction treatments, CT appears to provide improvement.
14
UI - 11556252
AU - Crino L; Cappuzzo F
TI -
[Role of gemcitabine in the treatment of advanced non-small cell lung
cancer: review of the main phase II and phase III trials]
SO - Anticancer Drugs 2001 Jul;12 Suppl 3():S9-13
AD - Division d'Oncologie Medicale, Hopital Bellaria, Bologne, Italie.
lucio.crino@ausl.bo.it
Marked advances in the treatment of non-small cell lung cancer (NSCLC)
have been made thanks to new agents. Among these agents, gemcitabine
appears to be a major compound in advanced stage NSCLC chemotherapy. To
start with, several phase III trials (conducted in Europe and in the
USA) studied the gemcitabine/cisplatin combination (GC): US study
protocois compared GC to cisplatin alone, to the standard treatment
(etoposide/cisplatin) or to platinum/taxane doublets; in these studies,
as a result of treatment with GC, a higher survival rate was observed. A
study conducted in Italy, which is undergoing analysis, observes GC
versus paclitaxel/carboplatin versus cisplatin/vinorelbine. In addition,
in newer clinical protocols, it was observed that gemcitabine combined
with taxanes or with vinorelbine demonstrated efficacy at least equal to
that of combinations with platinum analogs. Newer agents acting on
epithelial growth factor are also undergoing evaluation.
15
UI - 11772232
AU - Tester W; Mora J
TI -
Innovative treatments for non-small cell lung cancer.
SO - Expert Opin Investig Drugs 2001 Jun;10(6):1021-32
AD - Albert Einstein Cancer Center, 5501 Old York Road, Philadelphia, PA
19141-3098, USA. testerb@aehn2.einstein.edu
Lung cancer remains the most frequent and most lethal cancer worldwide.
Non-small cell lung cancer (NSCLC) comprises the vast majority of the
histological types. Surgery remains the standard therapy for early stage
disease but for advanced stage disease, modern treatment is
unsatisfactory. However, during the past ten years, improvements in
response and survival have been seen with the use of newer chemotherapy
regimens. Early studies of neo-adjuvant (pre-operative) chemotherapy for
resectable stage III patients have shown promising results. For patients
with non-resectable NSCLC platinum-based doublets are now established as
first-line treatment, either alone or in combination with radiotherapy.
Innovative non-platinum based combinations are actively being evaluated.
The most promising non-platinum agents at this time include gemcitabine,
paclitaxel, docetaxel, irinotecan and vinorelbine. These agents appear
to be effective as single agents and in combinations and also have
improved toxicity profiles. Several other systemic approaches are under
active evaluation; the most promising areas include anti-angiogenesis
agents, immunotoxins, interleukins, vaccines and molecular therapy.
16
UI - 11775848
AU - Wang J; Liu X; Jiang W
TI -
Co-transfection of MRP and bcl-2 antisense S-oligodeoxynucleotides
reduces drug resistance in cisplatin-resistant lung cancer cells.
SO - Chin Med J (Engl) 2000 Oct;113(10):957-60
AD - Department of Internal Medicine, School of Oncology, Beijing Medical
University, Beijing 100036, China. Wangjie_CC@yahoo.com
OBJECTIVE: To detect the influence of antisense s-oligodeoxynucleotides
(S-ODNs) of bd-2 and multidrug resistance-associated protein (MRP) genes
multidrug resistance-associated protein gene and bcl-2 antisense
S-oligodeoxynucleotides on cisplatin-resistant lung adenocarcinoma cell
line A549DDP which overexpresses both bcl-2 and MRP. METHODS: A549DDP
cells were treated with sense and antisense S-ODN mediated by
lipofection. Expression of MRP and bcl-2 mRNA and protein in the treated
cells was measured by RT-PCR and flow cytometry (FCM), respectively.
Apoptosis was identified by DNA electrophoresis and terminal
deoxynucleotidyl transferase (TdT)-mediated biotin dUTP nick
end-labeling (TUNEL). The degree of drug resistance of the treated cells
was detected by a cell viability 3'-[4,5-dimethylthiazol-2-yl]-2,
5-diphenyl-tefrazolium bromide thiazolylblue (MTT) assay. RESULTS:
Expression of bcl-2 and MRP significantly decreased in the cells treated
with bcl-2 or/and MRP antisense S-ODN for 48 h as compared to the cells
untreated and sense-treated (P < 0.05). Resistance to cisplatin in the
cells treated with bcl-2 or/and MRP antisense S-ODN decreased by 60.6%
(6.5 times), 56.4% (7.2 times) and 71.0% (4.8 times), respectively,
which paralleled the decrease of bcl-2 and MRP expression. Similarly,
the resistance to etoposide and epirubicin in antisense-treated cells
also reduced in parallel to decreases of the two gene expressions. The
drug resistance in sense-treated cells was similar to that in untreated
cells. Statistically significant dose- and concentration-dependent
increases of apoptotic cells were observed in the groups exposed to 100
mumol/L cisplatin for 48 h after treatment by bcl-2 or/and MRP
antisense. CONCLUSION: Bcl-2 and MRP were at least additive and possibly
synergistic in conferring drug resistance in a cisplatin-resistant lung
adenocarcinoma cell line. Antisense S-ODN could attenuate drug
resistance by promoting cells apoptosis, which might lead to a new
treatment for patients with non-small cell lung cancers (NSCLCs) who are
refractory to conventional chemotherapy.
17
UI - 11720426
AU - Sculier JP; Paesmans M; Lecomte J; Van Cutsem O; Lafitte JJ; Berghmans
TI -
T; Koumakis G; Florin MC; Thiriaux J; Michel J; Giner V; Berchier MC;
Mommen P; Ninane V; Klastersky J; European Lung Cancer Working Party
A three-arm phase III randomised trial assessing, in patients with
extensive-disease small-cell lung cancer, accelerated chemotherapy with
support of haematological growth factor or oral antibiotics.
SO - Br J Cancer 2001 Nov 16;85(10):1444-51
AD - Department of Medicine, Institut Jules Bordet, 1rue Heger-Bordet, B-1000
Bruxelles, Belgium.
The European Lung Cancer Working Party (ELCWP) designed a 3-arm phase
III randomised trial to determine the role of accelerated chemotherapy
in extensive-disease (ED) small-cell lung cancer (SCLC). Eligible
patients were randomised between the 3 following arms: (A) Standard
chemotherapy with 6 courses of EVI (epirubicin 60 mg m(-2), vindesine 3
mg m(-2), ifosfamide 5 g m(-2); all drugs given on day 1 repeated every
three weeks. (B) Accelerated chemotherapy with EVI administered every 2
weeks and GM-CSF support. (C) Accelerated chemotherapy with EVI and oral
antibiotics (cotrimoxazole). Primary endpoint was survival. 233 eligible
patients were randomised. Chemotherapy could be significantly
accelerated in arm B with increased absolute dose-intensity. Best
response rates, in the population of evaluable patients, were,
respectively for arm A, B and C, 59%, 76% and 70%. The response rate was
significantly higher in arm B in comparison to arm A (P = 0.04). There
was, however, no survival difference with respective median duration and
2-year rate of 286 days and 5% for arm A, 264 days and 6% for arm B and
264 days and 6% for arm C. Severe thrombopenia occurred more frequently
in arm B but without an increased rate of bleeding. Non-severe
infections were more frequent in arm B and severe infections were less
frequent in arm C. Our trial failed to demonstrate, in ED-SCLC, a
survival benefit of chemotherapy acceleration by using GM-CSF support.
18
UI - 11720427
AU - Baldini E; Ardizzoni A; Prochilo T; Cafferata MA; Boni L; Tibaldi C;
TI -
Neumaier C; Conte PF; Rosso R; Italian Lung Cancer Task Force
Gemcitabine, Ifosfamide and Navelbine (GIN): activity and safety of a
non-platinum-based triplet in advanced non-small-cell lung cancer
(NSCLC).
SO - Br J Cancer 2001 Nov 16;85(10):1452-5
AD - U.O. Oncologia Medica Ospedale S. Chiara, via Roma n.67, Pisa, Italy.
To evaluate activity and toxicity of a non platinum-based triplet
including Gemcitabine, Ifosfamide and Navelbine (GIN) in advanced NSCLC.
Stage IIIB/IV NSCLC patients with WHO PS < 2 and bidimensionally
measurable disease entered the study. Gemcitabine 1000 mg/sqm day 1 and
1000-800 mg/sqm day 4, Ifosfamide 3 g/sqm day 1 (with Mesna), Navelbine
25 mg/sqm day 1 and 25-20 mg/sqm day 4 were administered intravenously
every 3 weeks. Objective responses (ORs) were evaluated every 2 courses:
a maximum of 6 courses were administered in responding patients.
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. Fifty
patients entered the study. Main characteristics of the 48 evaluated
patients were: median age 63 years, ECOG performance status 0 = 65%,
stage IV disease 79% and non-squamous histology 71%. The total number of
courses administered was 200, median per patient 4 (range 1-6).
Toxicities were evaluated according to WHO criteria: neutropenia grade
3-4 occurred in 47% of the courses; thrombocytopenia grade 3-4 in 6.6%;
anaemia grade 3 in 3.5%. Twelve episodes of febrile neutropenia were
reported and three patients required hospital admission. No toxic death
was reported. Non-haematological toxicity, including skin rash, alopecia
and fatigue, were generally. Twenty-five 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%. This non-platinum-based
outpatient triplet showed promising activity against NSCLC with
myelosuppression, in particular neutropenia, being dose-limiting. The
GIN regimen may represent a valuable alternative to standard
platinum-based doublets and triplets in the treatment of advanced NSCLC
and further studies with this platinum-free combination are warranted.
19
UI - 11720428
AU - Huisman C; Biesma B; Postmus PE; Giaccone G; Schramel FM; Smit EF
TI -
Accelerated cisplatin and high-dose epirubicin with G-CSF support in
patients with relapsed non-small-cell lung cancer: feasibility and
efficacy.
SO - Br J Cancer 2001 Nov 16;85(10):1456-61
AD - Department of Pulmonary Diseases, University Hospital Vrije
Universiteit, Amsterdam, The Netherlands.
The purpose of this study is to determine whether it is feasible to
administer high-dose epirubicin (135 mg m(-2)) combined with a fixed
dose of cisplatin every 2 weeks with G-CSF support in patients with
metastatic non-small-cell lung cancer (NSCLC). Subsequently, the
efficacy of the recommended dose of this regimen was tested in a phase
II study in patients with relapsed NSCLC. In the initial feasibility
study at least 6 patients were entered at each of the 4 dose levels
tested. A fixed dose of cisplatin 60 mg m(-2) was given. Epirubicin was
administered at 120 mg m(-2) on dose level 1, 135 mg m(-2) on dose level
2 and 3 and 135 mg m(-2) on dose level 4. Patients treated at dose level
3 and 4 received G-CSF support on days 3-12. Cycles were repeated every
3 weeks on the first 3 dose levels and every 2 weeks on the fourth dose
level. A total of 27 patients were then treated on dose level 4, which
appeared to be feasible in the initial study. In the initial study, a
total of 86 courses were administered. Haematological toxicity was the
principal side effect. None of the patients encountered dose-limiting
toxicity in the first course, which confirmed that epirubicin 135 mg
m(-2) could be combined with cisplatin 60 mg m(-2) and accelerated by
G-CSF support to a 14-day-schedule. In the subsequent phase II study
with this schedule, 89 courses were administered. The relative dose
intensity of cisplatin and epirubicin was 0.90 and 0.91, respectively.
Myelosuppression was frequent with 70% and 63% of patients experiencing
WHO grade III or IV leukocytopenia and thrombocytopenia, respectively. 6
cases of febrile neutropenia were observed, with 2 treatment-related
deaths. Non-haematological toxicity consisted mainly of nausea and
vomiting, which was grade III in 22% of patients. Renal toxicity grade I
and II occurred in 37% and 4% of patients, respectively. 55% of these
patients had received prior cisplatin-containing chemotherapy. On an
intention-to-treat basis 9 partial responses were recorded in 27
patients (33%; 95% confidence interval, 15%-51%). Accelerated cisplatin
and high-dose epirubicin with G-CSF support is a feasible and promising
regimen in relapsed NSCLC. Myelosuppression limits the use of this
regimen in the second-line setting to a selected group of patients with
a good performance status. Since the activity of this regimen is
encouraging, it is probably best studied in untreated patients.
20
UI - 11589488
AU - Cuomo AM; Robustelli della Cuna FS; Baiardi P; Torazzo R; Preti P;
TI -
Robustelli della Cuna G
Three conventional-drug combination (ifosfamide, carboplatin,
etoposide--ICE regimen) in advanced non-small cell lung cancer (NSCLC).
SO - J Chemother 2001 Aug;13(4):434-9
AD - Divisione di Oncologia Medica, Fondazione S. Maugeri Clinica del Lavoro
e della Riabilitazione (IRCCS), Istituto Scientifico di Pavia, Italy.
Fifty consecutive patients with stage IIIB-IV non-small cell lung cancer
(NSCLC) received the ICE regimen at intermediate doses (ifosfamide 1
g/m2, carboplatin 120 mg/m2, etoposide 80 mg/m2, day 1 to 3, q.4 weeks,
for a maximum of 6 cycles). Overall 2 complete response (CR) and 10
partial response (PR) (overall response, OR: 24%, 95% C.I. 14-37%) were
observed. An additional 7 patients had stable disease (SD) lasting more
than 6 months, therefore a clinical benefit (CR+PR+SD >6 mos) was
achieved in 19 patients (38%). Median time-to-progression (TTP) was 7
months and median overall survival (OS) was 11 months; 1- and 2-year
survival rates were 36% and 10%. The ICE regimen was well tolerated and
devoid of any cardiac, hepatic or neurologic toxicity. Moderate nausea
and vomiting were easily manageable, grade 2 alopecia was universal,
while hematological toxicity was mild (grade 2 leuko- and
thrombocytopenia). Due to its efficacy and safety profile, this 3-drug
regimen can be considered for routine community use.
21
UI - 11809985
AU - Clegg A; Scott DA; Hewitson P; Sidhu M; Waugh N
TI -
Clinical and cost effectiveness of paclitaxel, docetaxel, gemcitabine,
and vinorelbine in non-small cell lung cancer: a systematic review.
SO - Thorax 2002 Jan;57(1):20-8
AD - Southampton Health Technology Assessments Centre, Wessex Institute for
Health Research and Development, University of Southampton, Southampton
SO16 7PX, UK. a.clegg@soton.ac.uk
BACKGROUND: Lung cancer remains a devastating disease with few effective
treatment options. Recent developments in chemotherapy have led to
cautious optimism. This paper reviews the evidence on the clinical and
cost effectiveness of four of the new generation drugs for patients with
lung cancer. METHODS: A systematic review of randomised controlled
trials (RCTs) identified from 11 electronic databases (including
Medline, Cochrane library and Embase), reference lists and contact with
experts and industry was performed to assess clinical effectiveness of
paclitaxel, docetaxel, gemcitabine and vinorelbine. Clinical
effectiveness was assessed using the outcomes of patient survival,
quality of life, and adverse effects. Cost effectiveness was assessed by
development of a costing model and presented as incremental cost per
life year saved (LYS) compared with best supportive care (BSC). RESULTS:
Of the 33 RCTs included, five were judged to be of good quality, 10 of
adequate quality, and 18 of poor quality. Gemcitabine, paclitaxel, and
vinorelbine as first line treatment and docetaxel as second line
treatment appear to be more beneficial for non-small cell lung cancer
than BSC and older chemotherapy agents, increasing patient survival by
2-4 months against BSC and some comparator regimes. These gains in
survival do not appear to be at the expense of quality of life. Survival
gains were delivered at reasonable levels of incremental cost
effectiveness for vinorelbine, vinorelbine with cisplatin, gemcitabine,
gemcitabine with cisplatin, and paclitaxel with cisplatin regimens
compared with BSC. CONCLUSION: Although the clinical benefits of the new
drugs appear relatively small, their benefit to patients with lung
cancer appears to be worthwhile and cost effective.
22
UI - 11583195
AU - Merimsky O; Staroselsky A; Inbar M; Schwartz Y; Wigler N; Mann A; Marmor
TI -
S; Greif J
Correlation between c-erbB-4 receptor expression and response to
gemcitabine-cisplatin chemotherapy in non-small-cell lung cancer.
SO - Ann Oncol 2001 Aug;12(8):1127-31
AD - Department of Oncology, Tel-Aviv Sourasky Medical Center, Tel-Aviv
University, Israel. merimsky@zahav.net.il
BACKGROUND: While the overexpression of c-erbB gene family in several
malignancies is associated with poorer prognosis, the association
between the expression of the cellular markers and the response to
chemotherapy is not yet clear. In this study we investigated the
expression of c-erbB-4 receptor in NSCLC and correlated it with the
response to gemcitabine-cisplatin combination chemotherapy. PATIENTS AND
METHODS: Forty-three NSCLC patients with histologically or cytologically
proven disease were treated with gemcitabine-cisplatin combination
chemotherapy. Immunohistochemical stains for c-erbB-4 receptor were
performed in 20 cases on paraffin sections using the
avidin-biotin-peroxidase method. RESULTS: Two patients achieved complete
response (5%), and 16 achieved partial response (37%) yielding an
overall objective response rate of 42%. Minimal response was observed in
seven patients (16%) and disease stabilization in 7%.
Immunohistochemical stain was positive for the presence of c-erbB-4
receptor in 25% of patients, and negative in 75%. No response was
documented in c-erbB-4 positive patients (0 of 5) while an objective
response (complete, partial or minimal) was seen in 11 of 15 (73%)
c-erbB-4 negative patients. Negative stain for c-erbB-4 significantly
favored response to gemcitabine-cisplatin combination (P < 0.01).
CONCLUSION: C-erbB-4 expression status showed no correlation with
survival and cannot be accepted at this time as a guiding factor for
therapeutic management. These interesting results deserve further
evaluation in a large-scale prospective trial before treatment
recommendations on the basis of c-erbB-4 presence can be finally made.
23
UI - 11735678
AU - Plosker GL; Hurst M
TI -
Paclitaxel: a pharmacoeconomic review of its use in non-small cell lung
cancer.
SO - Pharmacoeconomics 2001;19(11):1111-34
AD - Adis International Limited, Auckland, New Zealand. demail@adis.co.nz
A number of first-line chemotherapy options for patients with advanced
non-small cell lung cancer (NSCLC) are advocated in treatment guidelines
and/or by various clinical investigators. Platinum-based chemotherapy
has clearly demonstrated efficacy in patients with advanced NSCLC and is
generally recommended as first-line therapy, although there is
increasing interest in the use of non-platinum chemotherapy regimens.
Among the platinum-based combinations currently used in clinical
practice are regimens such as cisplatin or carboplatin combined with
paclitaxel, vinorelbine, gemcitabine, docetaxel or irinotecan. The
particular combinations employed may vary between institutions and
geographical regions. Several pharmacoeconomic analyses have been
conducted on paclitaxel in NSCLC and most have focused on its use in
combination with cisplatin. In terms of clinical efficacy,
paclitaxel-cisplatin combinations achieved significantly higher response
rates than teniposide plus cisplatin or etoposide plus cisplatin
(previously thought to be among the more effective regimens available)
in two large randomised trials. One of these studies showed a survival
advantage for paclitaxel plus cisplatin [with or without a granulocyte
colony-stimulating factor (G-CSF)] compared with etoposide plus
cisplatin. A Canadian cost-effectiveness analysis incorporated data from
one of the large randomised comparative trials and showed that the
incremental cost per life-year saved for outpatient administration of
paclitaxel plus cisplatin versus etoposide plus cisplatin was $US 22181
(30619 Canadian dollars; $Can) [1997 costs]. A European analysis
incorporated data from the other large randomised study and showed
slightly higher costs per responder for paclitaxel plus cisplatin than
for teniposide plus cisplatin in The Netherlands ($US 30769 vs $US
29592) and Spain ($US 19 923 vs $US 19724) but lower costs per responder
in Belgium ($US 22852 vs $US 25000) and France ($US28 080 vs $US 34747)
[1995/96 costs]. In other cost-effectiveness analyses, paclitaxel plus
cisplatin was associated with a cost per life-year saved relative to
best supportive care of approximately $US 10000 in a US study (year of
costing not reported) or $US 11200 in a Canadian analysis ($Can 15400;
1995 costs). Results were less favourable when combining paclitaxel with
carboplatin instead of cisplatin and particularly when G-CSF was added
to paclitaxel plus cisplatin. The Canadian study incorporated the
concept of extended dominance in a threshold analysis and ranked
paclitaxel plus cisplatin first among several comparator regimens
(including vinorelbine plus cisplatin) when the threshold level was $Can
75000 ($US 54526) per life-year saved or per quality-adjusted life-year
gained (1995 values). CONCLUSION: Current treatment guidelines for
advanced NSCLC recognise paclitaxel-platinum combinations as one of the
first-line chemotherapy treatment options. In two large head-to-head
comparative clinical trials, paclitaxel plus cisplatin was associated
with significantly greater response rates than cisplatin in combination
with either teniposide or etoposide, and a survival advantage was shown
for paclitaxel plus cisplatin (with or without G-CSF) over etoposide
plus cisplatin. There are limitations to the currently available
pharmacoeconomic data and further economic analyses of
paclitaxel-carboplatin regimens are warranted, as this combination is
widely used in NSCLC and appears to have some clinical advantages over
paclitaxel plus cisplatin in terms of ease of administration and
tolerability profile. Nevertheless, results of various
cost-effectiveness studies support the use of paclitaxel-platinum
combinations, particularly paclitaxel plus cisplatin, as a first-line
chemotherapy treatment option in patients with advanced NSCLC.
24
UI - 11826488
AU - Gorbunova VA; Orel NF; Semina OV; Besova NS; Kadagidze ZG
TI -
[Nitrullin -- a new original Russian drug of the nitrosomethylurea
group]
SO - Vopr Onkol 2001;47(6):680-3
AD - N.N. Blokhin Center for Oncology Research, Russian Academy of Medical
Sciences, Moscow.
Hematologic thrombopenia and leukopenia formation limits use of
nitrullin as a toxic hazard. The drug showed moderate effect in treating
inoperable non-small cell cancer of the lung and satisfactory end
results. The treatment had marked symptomatic effect in patients with
this cancer and, as a consequence, improved the quality of life.
Nutrullin had immuno-modulating effect. Its application alone or in
combination with VPN showed good results in the management of small-cell
cancer of the lung.
25
UI - 11776031
AU - Xu G; Rong T; Lin P
TI -
Adjuvant chemotherapy following radical surgery for non-small-cell lung
cancer: a randomized study on 70 patients.
SO - Chin Med J (Engl) 2000 Jul;113(7):617-20
AD - Tumor Hospital, Sun Yat-Sen University of Medical Sciences, Guangzhou
510060, China. nkzl@gzsums.edu.cn
OBJECTIVE: To evaluate the efficacy of adjuvant chemotherapy after
radical surgery for non-small-cell lung cancer (NSCLC). METHODS: Seventy
patients with NSCLC (stages I-III) undergoing radical surgery were
randomized into two groups. Group 1 (n = 35): combination group, which
received adjuvant chemotherapy with cyclophosphamide 300 mg/m2,
vincristine 1.4 mg/m2, adriamycin 50 mg/m2, and lomustine 50 mg/m2 on
day 1, and cisplatin 20 mg/m2 on days 1-5. The treatment was repeated
every 4-6 weeks for 4 cycles, followed by oral administration of
ftorafur (FT-207) 600-900 mg/d for 1 year. Group 2 (n = 35): surgery
group, which received surgical treatment only. RESULTS: The overall
5-year survival rate was 48.6% in the combination group versus 31.4% in
the surgery group, and difference between the two groups was not
statistically significant (chi 2 = 3.09, P > 0.05). The 5-year survival
rate for patients with stage III disease was 44% and 20.8% in the
combination and surgery groups, respectively, showing a statistically
significant difference (chi 2 = 5.28, P < 0.025). The 5-year survival
rates of patients in stages I-II in the two groups were 60.0% and 54.5%,
respectively, and were not significantly different (chi 2 = 0.03, P >
0.75). CONCLUSION: Postoperative adjuvant chemotherapy provides
statistically significant improvement in the 5-year survival rate only
in patients with stage III NSCLC.
26
UI - 11481083
AU - Sanchez de la Rosa R; Ruiz Echeverria J; Guillen Grima F
TI -
[Assessment of paclitaxel treatment of non-small-cell lung cancer]
SO - Med Clin (Barc) 2001 Jul 7;117(5):167-71
AD - Departamento de Operaciones Clinicas. Quintiles, S.L. Madrid.
BACKGROUND: Our goal was to assess the effectiveness of paclitaxel
therapy in patients with non-small-cell lung cancer (NSCLC) by means of
a meta-analysis of published clinical trials. MATERIAL AND METHOD: We
carried out a search of controlled and randomized clinical trials which
evaluated treatment with paclitaxel in patients with NSCLC from January
without restrictions in the publication language. We also performed a
sensitivity analysis and an analysis of sample heterogeneity. RESULTS:
Six randomized and controlled studies fulfilled the inclusion criteria.
Results from the analysis of effectiveness favoured significantly
treatment with paclitaxel (OR 95% total responders: 1.42 [1.16-1.74]; p
= 0.07). These results remained unchanged with the sensitivity analysis.
Analysis of survival after 1 year of treatment was not significant (OR
95% 0.96 [0.79-1.17]; p = 0.2) CONCLUSIONS: Paclitaxel in patients with
NSCLC offers a therapeutic advantage over other chemotherapy regimes
with an overall OR of 1.42. However, this therapy does not appear to
offer a significant survival advantage after 1 year.
27
UI - 11697832
AU - Vansteenkiste JF; Vandebroek JE; Nackaerts KL; Weynants P; Valcke YJ;
TI -
Verresen DA; Devogelaere RC; Marien SA; Humblet YP; Dams NL; The Leuven
Lung Cancer Group
Clinical-benefit response in advanced non-small-cell lung cancer: A
multicentre prospective randomised phase III study of single agent
gemcitabine versus cisplatin-vindesine.
SO - Ann Oncol 2001 Sep;12(9):1221-30
AD - University Hospital Gasthuisberg, Leuven, Belgium.
johan.vansteenkiste@uz.kuleuven.ac.be
BACKGROUND: The modest improvement in median survival of advanced
non-small-cell lung cancer (NSCLC) by cisplatin-based chemotherapy has
led to the current opinion that clinical benefit for the patient is at
least as important an end-point as objective response rate (ORR) or
survival. Clinical benefit response was the primary end-point of this
prospective randomised trial in symptomatic, advanced stage IIIB/IV
NSCLC, comparing single agent gemcitabine (GEM) to cisplatin-based
chemotherapy. PATIENTS AND METHODS: Patients received either GEM (1000
mg/m2, days 1, 8 and 15) or cisplatin (100 mg/M2, day 1) plus Vindesine
(3 mg/m2, days 1 and 15) (PV), both every four weeks. Clinical benefit
was measured by a simple metric based on changes in a visual analogue
symptom score list, the Karnofsky performance status and the weight.
RESULTS: One hundred sixty-nine patients were randomised (84 GEM, 85
PV). Prognostic factors and baseline symptoms were well balanced between
the two arms. Most of the the objective responders and about half of the
patients with disease stabilisation experienced clinical benefit.
Compared to PV, a significantly larger number of GEM-treated patients
experienced a clinical benefit (48.1 vs. 28.9%, P = 0.03) that lasted
significantly longer (median duration 16 vs. 10 weeks, P = 0.01). No
important differences in ORR, time-to-progression or median survival
were observed. Grade 3 + 4 toxicity was significantly higher in the
PV-group for leukopenia (P = 0.0003), neutropenia (P < 0.0001),
nausea/vomiting (P = 0.0006), alopecia (P < 0.0001), and neurotoxicity
(P = 0.04). Some severe pulmonary toxicity to GEM was noted. CONCLUSION:
Comparison of GEM with cisplatin-based therapy in symptomatic, advanced
NSCLC demonstrates that GEM produces significantly a stronger and
longer-lasting clinical benefit, probably due to its equal effectiveness
in terms of ORR, time-to-progression or survival, combined with
significantly less severe therapy-related toxicity.
28
UI - 11697833
AU - Skarlos DV; Samantas E; Briassoulis E; Panoussaki E; Pavlidis N;
TI -
Kalofonos HP; Kardamakis D; Tsiakopoulos E; Kosmidis P; Tsavdaridis D;
Tzitzikas J; Tsekeris P; Kouvatseas G; Zamboglou N; Fountzilas G
Randomized comparison of early versus late hyperfractionated thoracic
irradiation concurrently with chemotherapy in limited disease small-cell
lung cancer: a randomized phase II study of the Hellenic Cooperative
Oncology Group (HeCOG).
SO - Ann Oncol 2001 Sep;12(9):1231-8
AD - Athens Medical Center, Greece. hecogoff@otenet.gr
BACKGROUND: Concurrent platinum etoposide chemotherapy given in
combination with hyperfractionated thoracic radiation therapy (HTRT) in
limited disease (LD) small cell lung cancer (SCLC) is associated with a
high response rate and significant prolongation of survival. Given these
results, the Hellenic Cooperative Oncology Group (HeCOG) performed a
multicenter randomized phase II study in patients with LD SCLC to
evaluate the timing of HTRT (early vs. late) when given concurrently
with chemotherapy. PATIENTS AND METHODS: To be e
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