A phase II study of CPT-11, a new derivative of camptothecin, for previously untreated non-small-cell lung cancer.

Fukuoka, Masahiro; Niitani, Hisanobu; Suzuki, Atsushi; Motomiya, Masakichi; Hasegawa, Kazuo; Nishiwaki, Yutaka; Kuriyama, Takayuki; Ariyoshi, Y; Negoro, Shunichi; Masuda, Noriyuki

doi:10.1200/jco.1992.10.1.16

Cited by 401 publications

(117 citation statements)

References 13 publications

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“…As expected, leucopenia and diarrhoea, which are typical toxicities of CPT-1 I (Fukuoka et al, 1992), were the major toxicities of this combination regimen, with the most severe toxicities occurring during cycle I (Table 3). The marked interpatient variation in the toxicities, which is a well-known feature of CPT-11 (Masuda et al, 1992b;, was also noted in this trial.…”

Section: Discussionsupporting

confidence: 75%

“…Patients who could tolerate cycle 1 without major toxic effects were less likely to experience severe toxicities in subsequent cycles without dose adjustments. Despite the dose modification procedure, in which CPT-I I was withheld if the leucocyte count was < 3000 il-I when treatment was due, grade 3 or 4 leucopenia more frequently occurred in this trial than in a previous phase II trial of CPT-11 given as a single agent (46% vs 25%) (Fukuoka et al, 1992), suggesting at least an additive leucopenic effect in combination with cisplatin. With the availability of recombinant human granulocyte colony-stimulating factor (rhG-CSF), it has become possible to reduce the severity and duration of leucopenia induced by cytotoxic chemotherapy (Gabrilove et al, 1988).…”

Section: Discussionmentioning

confidence: 65%

“…The response rate of 32% to CPT-11 for NSCLC is very encouraging (Fukuoka et al, 1992). Both CPT-11 and cisplatin are active against NSCLC.…”

mentioning

confidence: 91%

“…Irinotecan (CPT-11) is a water-soluble camptothecin derivative that targets DNA topoisomerase I. CPT-11 has shown a strong anti-tumour activity as a single agent against a broad spectrum of experimental tumours (Kunimoto et al, 1987;Matsuzaki et al, 1988) as well as against various human malignancies including lung cancer (Ohno et al, 1990;Negoro et al, 1991b;Tacheuchi et al, 1991;Fukuoka et al, 1992; Masuda et al, 1992a;Shimada et al, 1993).…”

mentioning

confidence: 99%

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

Masuda

Fukuoka²,

Fujita³

et al. 1998

Br J Cancer

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Summary A phase trial of the combination of irinotecan (CPT-11) with cisplatin in advanced non-small cell lung cancer (NSCLC) showed a very promising response rate of 54% in previously untreated NSCLC patients. This study was conducted to confirm the activity and toxicities of CPT-11 and cisplatin combination for previously untreated NSCLC in a multi-institutional phase 11 study. Seventy patients with stage IIIB or IV NSCLC received CPT-11 60 mg m-2 intravenously (IV) on days 1, 8 and 15, and cisplatin 80 mg m-2 (IV) on day 1 every 4 weeks. Assessments were made of response, survival and toxicities. Sixty-nine were eligible, and evaluable for toxicities and survival, and 64 patients evaluable for response. Thirty-three patients (52%; 95% confidence interval 39-64%) achieved an objective response, with one complete response (2%) and 32 partial responses (50%). The median duration of response was 19 weeks and the overall median survival time was 44 weeks. The 1-year survival rate was 33%. The major toxic effects were leucopenia and diarrhoea. Grade 3 or 4 leucopenia, neutropenia, and diarrhoea occurred in 32 patients (46%), 53 patients (80%), and 13 patients (19%) respectively. A combination of CPT-11 and cisplatin is very effective against non-small-cell lung cancer with acceptable toxicities.

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Section: Discussionsupporting

confidence: 75%

Section: Discussionmentioning

confidence: 65%

“…The response rate of 32% to CPT-11 for NSCLC is very encouraging (Fukuoka et al, 1992). Both CPT-11 and cisplatin are active against NSCLC.…”

mentioning

confidence: 91%

mentioning

confidence: 99%

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

Masuda

Fukuoka²,

Fujita³

et al. 1998

Br J Cancer

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“…As a result, new drugs with demonstrated activity against NSCLC, such as the taxanes (Gatzemeier et al, 1995;Fossella et al, 1995), topoisomerase inhibitors (Fukuoka et al, 1992), gemcitabine (Noble and Goa, 1997) and vinorelbine (Lilenbaum and Grece, 1993;Goss et al, 1997) have aroused considerable interest. In particular, vinorelbine has been shown to increase survival in patients aged more than 70 years in comparison with the best supportive care alone (ELCVISG, 1999), and the favourable toxicological profile of gemcitabine allows its use in both unfit and elderly patients.…”

mentioning

confidence: 99%

Gemcitabine plus vinorelbine in elderly or unfit patients with non-small cell lung cancer

et al. 2000

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Summary Cisplatin-based combinations are efficacious in increasing the overall survival of patients with non-small cell lung cancer (NSCLC), but their toxicity makes them unsuitable for elderly and unfit patients. The primary objective of this non-randomized phase II study was to evaluate the feasibility and activity of the gemcitabine plus vinorelbine combination in previously untreated elderly and/or unfit patients with measurable stage III or IV NSCLC. Forty-three patients aged ≥ 65 years or with contraindications against cisplatin treatment (36 males and seven females: median age 66 years; range 48-75: PS 0 = 11, PS 1 = 19, PS 2 = 13) received intravenous (i.v.) gemcitabine 1000 mg m -2 , followed by vinorelbine 25 mg m -2 i.v. on day 1 and 8 every 21 days. Fifteen patients (34.9%) achieved partial remission (confidence interval: 27.6-42.2%) for a median duration of 6 months; the median survival of these patients has not yet been reached. A further 15 had stable disease for a median of 4 months and a median survival of 7 months. The 10 patients (23.2%) who experienced disease progression had a median survival of 4 months. Three patients are not evaluable. The 1-year actuarial survival rate is 31.1%. The treatment was well tolerated: only 35% of the patients had grade 3 or 4 granulocytopenia on day 14, none experienced episodes of neutropenic fever, and there was no evidence of severe haematological toxicity upon recycling. Only 9% of the patients suffered from gastrointestinal toxicity (grade 3); increased but reversible transaminase levels were observed in 11.6%. In conclusion, the results of this phase II study show that the combination of gemcitabine and vinorelbine is active and well tolerated in NSCLC, and thus encourage its use in elderly or unfit patients.

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In vitro augmentation of antitumor effect in combination with CPT-11 and CDDP for human colorectal cancer

Tsunoda¹,

Tanimura²,

Hotta³

et al. 2000

J. Surg. Oncol.

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A phase II study of CPT-11, a new derivative of camptothecin, for previously untreated non-small-cell lung cancer.

Abstract: CPT-11 is a very active agent for NSCLC with acceptable toxicities. Further trials in combination with other agents for this disease are warranted.

Cited by 401 publications

References 13 publications

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

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

Gemcitabine plus vinorelbine in elderly or unfit patients with non-small cell lung cancer

In vitro augmentation of antitumor effect in combination with CPT-11 and CDDP for human colorectal cancer

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