Randomized Phase III Intergroup Trial of Etoposide and Cisplatin With or Without Paclitaxel and Granulocyte Colony-Stimulating Factor in Patients With Extensive-Stage Small-Cell Lung Cancer: Cancer and Leukemia Group B Trial 9732

Niell, Harvey B.; Herndon, James E.; Miller, Antonius A.; Watson, Dorothy; Sandler, Alan; Kelly, Karen; Marks, Randolph S.; Perry, M. J.; Ansari, Rafat; Otterson, Grefory; Ellerton, John; Vokes, Everett E.; Green, Mark R.

doi:10.1200/jco.2005.09.071

Cited by 171 publications

(94 citation statements)

References 22 publications

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“…As expected the most frequent toxic effect was myelosuppression with grade 3 -4 neutropenia recorded in 51% of the courses and seven episodes of febrile neutropenia. Toxicity data seemed to be comparable with those reported with standard CDE combination (grades 3 -4 neutropenia in 92% of the patients; febrile neutropenia in 24% of the patients) and slightly higher than those reported for the PE regimen (grade 3 -4 neutropenia ranged between 38 and 66% of the patients; febrile neutropenia ranged between 6 and 13% of the patients) (Roth et al, 1992;Ardizzoni et al, 2002;Niell et al, 2005). However, it should be noted that in our study no prophylactic G-CSF was used.…”

Section: Discussionsupporting

confidence: 83%

“…Consistent achievements were also reported in the second trial which evaluate the impact of adding paclitaxel to the standard PE doublet in ED patients. The triplet required the prophylactic use of G-CSF (Niell et al, 2005). The study showed a complete response rate of 10% for the doublet (standard arm) and of 16% for the paclitaxel-based triplet.…”

Section: Discussionmentioning

confidence: 99%

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Epirubicin/paclitaxel/etoposide in extensive-stage small-cell lung cancer: a phase I–II study

et al. 2006

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The aim of this study was to evaluate feasibility and toxicity of escalating doses of epirubicin and paclitaxel plus fixed dose of etoposide and to define the activity of the triplet in extensive disease small-cell lung cancer. Thirteen patients entered the phase I study: the maximum tolerated doses were epirubicin (EpiDX) 90 mg m À2 and paclitaxel (P) 175 mg m À2 with febrile neutropenia as dose-limiting toxicity. The recommended schedule for this regimen for the phase II study was EpiDX 75 mg m À2 , P 175 mg m À2 , etoposide (E) 100 mg m À2 intravenous (fixed dose) days 1 -3 with courses repeated every 21 days. The prophylactic use of colonystimulating factors (CSFs) was not allowed. Twenty patients entered the phase II trial: median age was 61 years (range 50 -70), median Eastern Cooperative Oncology Group performance status 0 (0 -2); nine patients had visceral disease and 17 had more than two metastatic sites. A total of 100 courses were administered with a median of 5 (range 1 -6) per patients. Main toxicity (NCI-CTC) was myelosuppression: neutropenia grades 3 and 4 in 16 and 35% of the courses, respectively. Seven episodes of febrile neutropenia were documented and one patient required hospital admission. Nonhaematological toxicity was moderate. Seven out of 19 evaluable patients achieved a complete response (37%), nine patients (47.3%) a partial response with an overall response rate of 84.2% ((95% confidence interval ¼ 60.4 -96.6)). In this poor prognostic population of patients the triplet epirubicin/paclitaxel/ etoposide showed high antitumour activity with mild nonhaematological side effects. The use of CSFs should be able to improve the haematological profile.

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Section: Discussionsupporting

confidence: 83%

Section: Discussionmentioning

confidence: 99%

Epirubicin/paclitaxel/etoposide in extensive-stage small-cell lung cancer: a phase I–II study

et al. 2006

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“…It is encouraging that the patients were older (median age, 69 vs 63 years) and included fewer females (6 vs 14 -26%) than in these other studies, and the 2-year survival rate (17.7%) and response rate (79%) were good and similar to those for irinotecan/cisplatin rather than cisplatin/etoposide. Recent large randomized trials of cisplatin/etoposide with or without newer cytotoxic agents have demonstrated a MST of 8.0 -10.6 months in previously untreated patients with ED-SCLC (De Marinis et al, 2003, Georgoulias et al, 2004Niell et al, 2005). In addition, a recent meta-analysis of randomized trials demonstrated that patients who received a regimen containing cisplatin had a significant increase in the probability of response and survival (Pujol et al, 2000;Hotta et al, 2004).…”

Section: Discussionmentioning

confidence: 99%

Phase II study of irinotecan combined with carboplatin in previously untreated small-cell lung cancer

et al. 2006

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To determine the efficacy and toxicity of irinotecan combined with carboplatin, we conducted a phase II trial. Eligibility criteria were: chemotherapy-naïve, small-cell lung cancer (SCLC), good performance status (PS: 0 -2), agep75 years, and adequate organ function. The patients' characteristics were: male/female ¼ 56/5; PS 0/1/2 ¼ 19/38/4; median age (range) ¼ 68 years(51 -75 years); limited disease (LD)/extensive disease (ED) ¼ 27/34. The patients received irinotecan (50 mg m À2 ) on days 1, 8, and 15, and carboplatin (AUC 5, Chatelut formula) on day 1 every 4 weeks. In total, 61 patients were eligible and all were evaluated. In all, 31 patients were treated with four or more courses of chemotherapy. Of the patients, 17 showed a complete response (CR), 34 showed a partial response (PR), nine had stable disease (SD), and one had progressive disease (PD). The overall response rate was 84% (95% confidence interval (CI), 72 -91%; LD 89%, ED 79%) and the CR rate was 28% (95%CI, 17 -41%; LD 37%, ED 21%). The median time to tumour progression was 6.1 (LD 6.4, ED 5.4) months. The medial survival time was 15.0 (LD 20.0, ED 9.7) months, and the 2-year and 5-year survival rates were 31.1% (LD 48.1%, ED 17.7%) and 9.5% (LD 11.1%, ED 5.9%), respectively. Grade 3 or 4 leucopenia, neutropenia, thrombocytopenia, anaemia, and diarrhoea occurred in 33, 74, 41, 39, and 13% of cases, respectively. In conclusion, the combination of irinotecan and carboplatin is an active and well-tolerated regimen in cases of SCLC.

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“…Both trials led to similar conclusions and failed to show a benefit in survival for the experimental arm, but reported an increase in haematological and non-haematological toxicity, and a higher rate of toxicity-related death (Mavroudis et al, 2001;Niell et al, 2005).…”

Section: Treatment Of Edmentioning

confidence: 87%

Treatment options for small cell lung cancer – do we have more choice?

et al. 2010

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Randomized Phase III Intergroup Trial of Etoposide and Cisplatin With or Without Paclitaxel and Granulocyte Colony-Stimulating Factor in Patients With Extensive-Stage Small-Cell Lung Cancer: Cancer and Leukemia Group B Trial 9732

Abstract: PET did not improve the time to progression or survival in patients with extensive SCLC compared with EP alone and was associated with unacceptable toxicity.

Cited by 171 publications

References 22 publications

Epirubicin/paclitaxel/etoposide in extensive-stage small-cell lung cancer: a phase I–II study

Epirubicin/paclitaxel/etoposide in extensive-stage small-cell lung cancer: a phase I–II study

Phase II study of irinotecan combined with carboplatin in previously untreated small-cell lung cancer

Treatment options for small cell lung cancer – do we have more choice?

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