2 ALTERNATIVE CHEMO REGIMENS FOR SMALL CELL CANCER?

J Clin Oncol. 2008 Sep 10;26(26):4261-7.

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Irinotecan plus carboplatin versus oral etoposide plus carboplatin in extensive small-cell lung cancer: a randomized phase III trial.

Hermes A, Bergman B, Bremnes R, Ek L, Fluge S, Sederholm C, Sundstrøm S, Thaning L, Vilsvik J, Aasebø U, Sörenson S.

Department of Pulmonary Oncology, Grosshansdorf Hospital, Wöhrendamm 80, 22927 Grosshansdorf, Germany. pahermes@hotmail.com.

PURPOSE: A Japanese randomized trial showed superior survival for patients with extensive-disease (ED) small-cell lung cancer (SCLC) receiving irinotecan plus cisplatin compared with etoposide plus cisplatin. The present trial evaluated the efficacy of irinotecan plus carboplatin (IC) compared with oral etoposide plus carboplatin (EC). PATIENTS AND METHODS: Patients with ED SCLC were randomly assigned to receive either IC, which consisted of carboplatin (area under the curve = 4; Chatelut formula) and irinotecan (175 mg/m2) intravenously both on day 1, or EC, which consisted of carboplatin as in IC and etoposide (120 mg/m(2)/d) orally on days 1 through 5. Courses were repeated every 3 weeks with four cycles planned. Doses were reduced by one third in patients with a WHO performance status (PS) of 3 to 4 and/or age older than 70 years. Primary end point was overall survival (OS). Secondary end points were quality of life (QOL) and complete response (CR) rate. RESULTS: Of 220 randomly assigned patients, 209 were eligible for analysis (IC, n = 105; EC, n = 104). Thirty-five percent were older than 70 years, and 47% had a PS of 2 to 4. The groups were well balanced with respect to prognostic factors. OS was inferior in the EC group (hazard ratio = 1.41; 95% CI, 1.06 to 1.87; P = .02). Median survival time was 8.5 months for IC compared with 7.1 months for EC. One-year survival rate was 34% for IC and 24% for EC. CR was seen in 18 IC patients compared with seven EC patients (P = .02). There were no statistically significant differences in hematologic grade 3 or 4 toxicity. Grade 3 or 4 diarrhea was more common in the IC group. QOL differences were small, with a trend toward prolonged palliation with the IC regimen. CONCLUSION: IC prolongs survival in ED SCLC with slightly better scores for QOL.

Thorax. 2008 Sep 11. [Epub ahead of print]

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Comparison of gemcitabine and carboplatin versus cisplatin and etoposide for patients with poor-prognosis small cell lung cancer.

Lee SM, James L, Qian W, Spiro S, Eisen T, Gower N, Ferry D, Gilligan D, Harper P, Prendiville J, Hocking M, Rudd R.

University College London Hospitals, United Kingdom.

BACKGROUND: Cisplatin and etoposide (PE) has been a standard treatment for patients with poor prognosis small cell lung cancer (SCLC). This non-inferiority design trial (registered as ISRCTN 39679215) aimed to determine whether gemcitabine and carboplatin (GC) has a similar survival but is less toxic with better quality of life (QoL). METHODS: Previously untreated SCLC patients with extensive disease or limited-stage with poor prognostic factors were randomly assigned to six, 3-weekly cycles of GC, or PE. RESULTS: 241 patients (121 GC and 120 PE) were recruited of which 216 (90%) had died. There was no difference in overall survival (HR 1.01, 95% CI 0.77 to 1.32). Median survival was 8.0 months and 8.1 months with GC and PE respectively.. Median progression-free survival was 5.9 months with GC and 6.3 months with PE. Grade 3 or 4 myelosuppressions were more frequent with GC (anaemia, 14% GC v 2% PE; leucopenia, 32% GC v 13% PE; thrombocytopenia, 22% GC v 4% PE) but these were not associated with increased hospital admissions, infections, or fatalities. More frequent grade 2-3 alopecia (68% PE v 17% GC) and nausea (43% PE v 26% GC) were seen with PE. GC patients received more chemotherapy as out-patients (89% GC vs 66% PE of treatment cycles). In QoL questionaires, more PE patients reported upset by hair loss (P=.004) and impaired cognitive functioning (P=0.04). CONCLUSIONS: GC is as effective as PE in terms of overall survival and progression-free survival, and has a toxicity profile more acceptable to patients.