A phase II trial of combination of CPT-11 and cisplatin for advanced non-small-cell lung cancer

Masuda, Noriyuki; Fukuoka, Masahiro; Fujita, Akihisa; Kurita, Yuichi; Tsuchiya, Satoshi; Nagao, Keiichi; Negoro, Shunichi; Nishikawa, H; Katakami, Nobuyuki; Nakagawa, Kazuhiko; Niitani, Hisanobu

doi:10.1038/bjc.1998.473

Cited by 59 publications

(44 citation statements)

References 25 publications

(24 reference statements)

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“…On the other hand, survival was fairly good. The MST (54 weeks) and 1-year survival rate (57%) were better than those reported previously with a combination of CPT-11 and CDDP (Masuda et al, 1998(Masuda et al, , 1999DeVore et al, 1999;Niho et al, 1999).…”

Section: Discussionmentioning

confidence: 59%

“…Based on these results, we initiated the present phase II study, assuming the expected response rate to be 70%. The previously reported results of a combination of CDDP and CPT-11 for advanced NSCLC are summarized in Table4 (Masuda et al, 1998(Masuda et al, , 1999DeVore et al, 1999;Niho et al, 1999). Though the response rate obtained in this phase II study was 45%, which was considerably lower than the expected response rate, it was comparable to the previously reported results.…”

Section: Discussionmentioning

confidence: 99%

“…and furthermore synergism between these 2 drugs was demonstrated in vitro (Kudoh et al, 1993), combination of CDDP and CPT-11 has been studied (Masuda et al, 1992(Masuda et al, , 1994(Masuda et al, , 1998DeVore et al, 1999). In a Japanese multi-institutional study, CDDP was given on day 1 and CPT-11 on days 1, 8 and 15.…”

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confidence: 99%

“…In a Japanese multi-institutional study, CDDP was given on day 1 and CPT-11 on days 1, 8 and 15. An objective response rate in the study remained to be about 50%, because dose-escalation was prevented by diarrhoea and leukopenia which were mainly caused by CPT-11 (Masuda et al, 1992(Masuda et al, , 1994(Masuda et al, , 1998. In order to take maximum advantage of the synergistic effects between CDDP and CPT-11 and to reduce the dose of CPT-11, Okayama Lung Cancer Study Group planned the fractionated administration in which both CDDP and CPT-11 were given on days 1 and 8, and has already performed a phase I study (Ueoka et al, 1999).…”

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confidence: 99%

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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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Section: Discussionmentioning

confidence: 59%

Section: Discussionmentioning

confidence: 99%

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confidence: 99%

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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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“…The first is a phase II study that achieves a high response rate of 54%, with 33% of patients alive at 1 year (Masuda et al, 1998). The second is a phase I dose-finding study of the same combination but given with concomitant radiotherapy in locally advanced disease.…”

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Where to go with new expensive treatments in NSCLC

Webb

O’Brien²

1998

Br J Cancer

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This month's journal reports two studies using the combination of irinotecan and cisplatin in advanced non-small-cell lung cancer. The first is a phase II study that achieves a high response rate of 54%, with 33% of patients alive at 1 year (Masuda et al, 1998). The second is a phase I dose-finding study of the same combination but given with concomitant radiotherapy in locally advanced disease. The initial doses chosen were of the order of 40% of the usual irinotecan weekly dose with 60 mg m-2 cisplatin. This chemoradiotherapy combination was not tolerated because of a number of toxicities, but in particular leucopenia. The study was stopped early but even at these low doses, a response rate of 67% was obtained (Yokoyama et al, 1998). This has important implications for the use of irinotecan with radiotherapy in both lung and bowel cancer (Yokoyama et al, 1998).Where do we take these new treatments and how do we make progress in the treatment of non-small-cell lung cancer? We now have five new drugs with activity in non-small-cell lung cancer and all of them priced in the range of between 6 and 30 times the cost of any of our previous regimens. This compounds the problem in non-small-cell lung cancer when the last new drug in the late 1980s, vinorelbine, has yet to be tested or accepted as standard treatment in this country. Currently, drug budgets are stretched to meet the increasing expenditure with our current 'cheap' regimens, never mind addressing new expensive treatments. It is a shame that we have come to the point when new treatments are not being hailed into clinical trials with enthusiasm and optimism, as currently there are no prospects that these new agents, if better, can then become standard treatments.Gemcitabine, the taxanes (paclitaxel, docetaxel), the topoisomerase I inhibitors (irinotecan, topotecan) and vinorelbine all have significant single-agent activity with response rates of at least 20% and encouraging survival data with acceptable toxicities (Table 1). There have now been numerous phase II studies investigating these agents in combination with platinum compounds, including the two in this issue. They have shown promising activity with relatively high response rates and 1-year survivals of 40% or more (Table 2). However, although promising, these phase II studies must be viewed with caution, and judgment must be reserved until the results of phase III randomized studies comparing these combinations to standard treatments become available.The commonest (standard) treatments for non-small-cell lung cancer in this country are cisplatin based, usually MVP (mitomycin, vinblastine and cisplatin) or MIC (mitomycin, ifosfamide and Received 15 May 1997 Accepted 15 May 1997 Correspondence to: MER O'Brien cisplatin), with cisplatin used at a dose of around 50 mg m-2. This differs to the USA where the cisplatin dose is usually higher and the combinations most frequently used are etoposide/cisplatin and vinblastine/cisplatin. The only randomized study comparing MIC, MVP (both using higher-dose cis...

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Clinical use of topoisomerase I inhibitors in anticancer treatment

Rodríguez‐Galindo

Radomski

Stewart

et al. 2000

Med. Pediatr. Oncol.

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The camptothecin analogs topotecan and irinotecan have shown to be among the most effective anticancer agents and, as S-phase specific agents, their antitumor effect is maximized when they are administered in protracted schedules. The documented activity as single agents in many adult and pediatric malignancies has been followed by their use in combination with other anticancer agents. These studies have shown promising results, and have placed topotecan and irinotecan in the first line treatment for some malignancies. However, studies to better determine the optimal schedules and sequence of combinations are needed.

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A phase II trial of combination of CPT-11 and cisplatin for advanced non-small-cell lung cancer

Cited by 59 publications

References 25 publications

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

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

Where to go with new expensive treatments in NSCLC

Clinical use of topoisomerase I inhibitors in anticancer treatment

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