Randomized study of paclitaxel-cisplatin versus cisplatin-teniposide in patients with advanced non-small-cell lung cancer. The European Organization for Research and Treatment of Cancer Lung Cancer Cooperative Group.

Giaccone, Giuseppe; Splinter, Ted A.W.; Debruyne, Channa; Kho, G. S.; Lianes, P.; Zandwijk, Nico van; Pennucci, M.C.; Scagliotti, G.; Meerbeeck, Jan P. van; Hoesel, Q. van; Curran, Desmond; Sahmoud, Tarek; Postmus, Pieter E.

doi:10.1200/jco.1998.16.6.2133

Cited by 244 publications

(82 citation statements)

References 20 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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“…Historically, sb-paclitaxel given in combination with carboplatin or cisplatin demonstrated a median overall survival (os) of 7.7-10 months and an orr of 17%-41% [7][8][9]11,14,[16][17][18]22 .…”

Section: Taxane-platinum Combinationsmentioning

confidence: 99%

Update on Taxanes in the First-Line Treatment of Advanced Non-Small-Cell Lung Cancer

Socinski¹

2014

Current Oncology

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standard-of-care options, and no single standardof-care regimen is superior in the treatment of advanced nsclc 7-10 . Thus, physicians rely on numerous factors to optimize treatment strategies, including histology, age, performance status, cost, tolerability, and convenience. The combination of a platinum agent with a taxane-either solvent-based (sb) paclitaxel (Taxol: Bristol-Myers Squibb, Princeton, NJ, U.S.A.) or docetaxel (Taxotere: SanofiAventis, Bridgewater, NJ, U.S.A.)-has a proven efficacy and safety profile in advanced nsclc 6 . The sb-paclitaxel-carboplatin regimen is among those most commonly used for the first-line treatment of advanced nsclc in the United States 11 .Recently, nab-paclitaxel, a 130-nm albuminbound ("nab") form of paclitaxel designed to use endogenous albumin pathways to increase intratumoural concentrations of the active drug, demonstrated improved antitumour activity and tolerability compared with sb-paclitaxel when both were used in combination with carboplatin in the first-line treatment of patients with advanced nsclc 12 . Based on the results of a phase iii trial, nab-paclitaxel in combination with carboplatin was approved in 2012 as first-line therapy for the treatment of locally advanced or metastatic nsclc in patients who are not candidates for curative surgery or radiation therapy 12,13 . The present review summarizes the clinical experience to date with taxanes in the first-line treatment of nsclc. DISCUSSION Taxane-Platinum CombinationsIn landmark nsclc studies, overall response rates (orrs) were higher with taxane-platinum combinations than with other chemotherapy regimens ( Table i). Historically, sb-paclitaxel given in combination with carboplatin or cisplatin demonstrated a median overall survival (os) of 7.7-10 months and an orr of 17%-41% [7][8][9]11,14,[16][17][18]22 . ABSTRACTBased on demonstrated favourable risk-benefit profiles, taxanes remain a key component in the first-line standard of care for advanced non-smallcell lung cancer (nsclc) and nsclc subtypes. In 2012, a novel taxane, nab-paclitaxel (Abraxane: Celgene Corporation, Summit, NJ, U.S.A.), was approved, in combination with carboplatin, for the first-line treatment of locally advanced or metastatic nsclc. The approval was granted because of demonstrated improved antitumour activity and tolerability compared with solvent-based paclitaxelcarboplatin in a phase iii trial. This review focuses on the evolution of first-line taxane therapy for advanced nsclc and the new options and advances in taxane therapy that might address unmet needs in advanced nsclc.

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“…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.…”

mentioning

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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Randomized study of paclitaxel-cisplatin versus cisplatin-teniposide in patients with advanced non-small-cell lung cancer. The European Organization for Research and Treatment of Cancer Lung Cancer Cooperative Group.

Abstract: Although survival was not improved, arm B offers a better palliation for advanced NSCLC patients than arm A.

Cited by 244 publications

References 20 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

Update on Taxanes in the First-Line Treatment of 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

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