Comparison of Survival and Quality of Life in Advanced Non–Small-Cell Lung Cancer Patients Treated With Two Dose Levels of Paclitaxel Combined With Cisplatin Versus Etoposide With Cisplatin: Results of an Eastern Cooperative Oncology Group Trial

Bonomi, Philip; Kim, KyungMann; Fairclough, Diane L.; Cella, David; Kugler, John W.; Rowinsky, Eric K.; Jiroutek, Michael R.; Johnson, David H.

doi:10.1200/jco.2000.18.3.623

Cited by 540 publications

(265 citation statements)

References 22 publications

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“…Previous studies of PTX (Belani et al, 1998;Giaccone et al, 1998;Bonomi et al, 2000), DTX (Kubota et al, 2002), GEM (Crino et al, 1999) and VNB (Le Chevalier et al, 1994;Martoni et al, 1998) were for comparison of a platinum compound plus a new agent vs an old platinum-based chemotherapy. Only the studies by Le Chevalier et al (1994) and Kubota et al (2002) reported significant differences in terms of survival based on the analysis scheduled in the protocol.…”

Section: Discussionmentioning

confidence: 99%

Randomised phase III trial of irinotecan combined with cisplatin for advanced non-small-cell lung cancer

Negoro

Masuda

Takada³

et al. 2003

Br J Cancer

136

109

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To determine a standard combination chemotherapy for patients with advanced non-small-cell lung cancer (NSCLC), we conducted a phase III trial of irinotecan (CPT-11) to test the hypotheses that CPT-11+cisplatin is superior to cisplatin+vindesine and that CPT-11 monotherapy is not inferior to cisplatin+vindesine. A total of 398 patients with previously untreated NSCLC were randomised to receive cisplatin+CPT-11 (CPT-P), cisplatin+vindesine (VDS-P) or CPT-11 alone (CPT). In the CPT-P arm, CPT-11 60 mg m À2 was administered on days 1, 8 and 15, and cisplatin 80 mg m À2 was administered on day 1. In the VDS-P arm, cisplatin 80 mg m À2 was administered on day 1, and vindesine 3 mg m À2 was administered on days 1, 8 and 15. In the CPT arm, CPT-11 100 mg m À2 was administered on days 1, 8 and 15. The median survival time was 50.0 weeks for patients on CPT-P, 45.6 weeks for those on VDS-P and 46.0 weeks for those on CPT (P ¼ 0.115, CPT-P vs VDS-P; P ¼ 0.089, CPT vs VDS-P), and the hazard ratio was 0.85 (95% confidence interval (CI): 0.65 -1.11) for CPT-P vs VDS-P and 0.83 (0.64 -1.09) for CPT vs VDS-P. The response rate was 43.7% for patients on CPT-P, 31.7% for those on VDS-P and 20.5% for those on CPT. Major adverse reactions were grade 4 neutropenia observed in 37, 54 and 8% of the patients on CPT-P, VDS-P and CPT, respectively; and grades 3 and 4 diarrhoea observed in 12, 3 and 15% of the patients, respectively. CPT-P therapy produces comparable survival to VDS-P in patients with advanced NSCLC. CPT-11 monotherapy is not inferior to VDS-P in terms of survival. The CPT-11-containing regimen is one of the most efficacious and well tolerated in the treatment of advanced NSCLC.

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Section: Discussionmentioning

confidence: 99%

Randomised phase III trial of irinotecan combined with cisplatin for advanced non-small-cell lung cancer

Negoro

Masuda

Takada³

et al. 2003

Br J Cancer

136

109

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“…In the past decade, cisplatin in combination with new anticancer drugs has been found to increase effectively, although modestly, patient survival in randomised trials and/or meta-analyses, when compared with cisplatin plus conventional anticancer drugs (Grilli et al, 1993;Le Chevalier et al, 1994;NSCLC collaborative group, 1995;Bonomi et al, 2000;Baggstrom et al, 2002;Raftopoulos et al, 2002;Schiller et al, 2002;Yana et al, 2002). Among these new anticancer drugs, vinorelbine was the first drug to show better survival, when in combination with cisplatin, than conventional anticancer drugs in combination with cisplatin, in a randomised phase III study (Le Chevalier et al, 1994).…”

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confidence: 99%

“…In spite of the fact that a phase III randomised trial showed better survival with paclitaxel plus cisplatin, when comparing etoposide with cisplatin (Bonomi et al, 2000), many studies have not demonstrated better survival with paclitaxel plus cisplatin or carboplatin, when compared with conventional chemotherapy (Giaccone et al, 1998;Gatzemeier et al, 2000;Raftopoulos et al, 2002). The dosage and schedule of the paclitaxel used varied widely among the different studies and, thus, probably had different therapeutic effects on the patients.…”

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confidence: 99%

A randomised phase II study of weekly paclitaxel or vinorelbine in combination with cisplatin against inoperable non-small-cell lung cancer previously untreated

Shih

et al. 2004

Br J Cancer

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Phase II studies have suggested that weekly paclitaxel has a higher response rate and better toxicity profile than the conventional schedule of once every 3 or 4 weeks. Our aim was to evaluate the efficacy of weekly paclitaxel plus cisplatin (PC) vs vinorelbine plus cisplatin (VC) in chemonaïve non-small-cell lung cancer (NSCLC) patients. From October 2000 to May 2002, 140 patients were enrolled. The treatment dose was P 66 mg m À2 intravenous infusion (i.v.) on days 1, 8, and 15, and C 60 mg m À2 i.v. on day 15, or V 23 mg m À2 i.v. on days 1, 8, and 15, and C 60 mg m À2 i.v. on day 15, every 4 weeks. In all, 281 cycles of PC and 307 cycles of VC were given to the patients in the PC and VC arms, respectively. There were 26 partial responses and one complete response (overall 38.6%) in the PC arm, and no complete responses, but 27 partial responses (overall 38.6%) in the VC arm. Myelosuppression was more common in the VC arm (Po0.001). Peripheral neuropathy and myalgia were significantly more common in the PC arm (Po0.001). The median time to disease progression was 6 months in the PC arm and 8.4 months in the VC arm (P ¼ 0.0344). The median survival time was 11.7 months in the PC arm and 15.4 months in the VC arm (P ¼ 0.297). We concluded that weekly PC is not suggested for NSCLC patients due to the relatively shorter progression-free survival and more common nonhaematological toxicities.

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“…The treatment outcomes of the present study were superior or at least comparable to the results of previous multi-institutional trials of a combination of CPT-11 plus CDDP (Masuda et al, 1998(Masuda et al, , 1999DeVore et al, 1999;Niho et al, 1999). Recently, superiority of 2-drug combinations of one of the newly developed agents, vinorelbine or paclitaxel, with CDDP to the representative CDDP-based chemotherapy in the 1980s such as CDDP plus vindesine or etoposide was reported in prospective randomized trials (Le Chevalier et al, 1994;Bonomi et al, 2000). However, no definitive conclusion was obtained in the 2 Japanese multi-institutional randomized trials comparing CPT-11 plus CDDP with CDDP plus vindesine (Masuda et al, 1999;Niho et al, 1999), although superiority of CPT-11 plus CDDP for stage IV patients was shown by the subset analysis of one trial (Masuda et al, 1999).…”

Section: Discussionmentioning

confidence: 99%

Fractionated administration of irinotecan and cisplatin for treatment of non-small-cell lung cancer: a phase II study of Okayama Lung Cancer Study Group

et al. 2001

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A phase II study of fractionated administration of irinotecan (CPT-11) and cisplatin (CDDP) in patients with non-small-cell lung cancer (NSCLC) was conducted. Between January 1996 and January 1998, 44 previously untreated patients with stage IIIB or IV NSCLC were enrolled. CDDP at a dose of 60 mg m –2 was given first and followed by CPT-11 at a dose of 50 mg m –2 . Both drugs were given by 1-hour infusion on days 1 and 8, and repeated every 4 weeks up to 4 cycles. 42 patients were evaluated for response and 44 for survival and toxicity. 20 patients (48%: 95% confidence interval 32–63%) achieved an objective response. The median duration of responses was 8 months, and the median survival time and the 1-year survival rate were 12.5 months and 56.8%, respectively. Major toxicities were neutropenia and diarrhoea. Grade 3 or 4 neutropenia occurred in 70.5% of the patients and one patient died of sepsis. Grade 3 or 4 diarrhoea was experienced in 25.0%, but manageable by conventional therapy. In conclusion, fractionated administration of CPT-11 and CDDP was highly effective for advanced NSCLC with manageable toxicities. © 2001 Cancer Research Campaign http://www.bjcancer.com

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Comparison of Survival and Quality of Life in Advanced Non–Small-Cell Lung Cancer Patients Treated With Two Dose Levels of Paclitaxel Combined With Cisplatin Versus Etoposide With Cisplatin: Results of an Eastern Cooperative Oncology Group Trial

Abstract: As a result of these observations, paclitaxel (135 mg/m(2)) combined with cisplatin has replaced etoposide plus cisplatin as the reference regimen in our recently completed phase III trial.

Cited by 540 publications

References 22 publications

Randomised phase III trial of irinotecan combined with cisplatin for advanced non-small-cell lung cancer

Randomised phase III trial of irinotecan combined with cisplatin for advanced non-small-cell lung cancer

A randomised phase II study of weekly paclitaxel or vinorelbine in combination with cisplatin against inoperable non-small-cell lung cancer previously untreated

Fractionated administration of irinotecan and cisplatin for treatment of non-small-cell lung cancer: a phase II study of Okayama Lung Cancer Study Group

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