Cooperative Group Research Endeavors in Small-cell Lung Cancer: Current and Future Directions

Current and Future Directions

Randeep Sangha; Primo N. Lara, Jr.; Alex A. Adjei; Paul Baas; Hak Choy; Laurie E. Gaspar; Glenwood Goss; Nagahiro Saijo; Joan H. Schiller; Everett E. Vokes; David R. Gandara

Disclosures

Clin Lung Cancer. 2009;10(5) 

In This Article

Japan Clinical Oncology Group

Although there are a number of cooperative oncology groups in Japan, JCOG and the North Japan Lung Cancer Study Group (NJLCSG) are particularly active in SCLC research efforts. JCOG draws from its 190 participating institutions to enroll patients into its trials. In SCLC, there are 3 ongoing phase III trials, in addition to 1 phase II protocol in development that is evaluating amrubicin in the relapsed/refractory setting ( Table 1 ). However, the featured trial at the 2008 ILCC was NJLCSG 0402, a randomized phase II trial comparing amrubicin with topotecan in previously treated SCLC. Sixty patients, stratified according to performance status and type of relapse (chemotherapy sensitive or refractory), were randomly assigned to receive amrubicin 40 mg/m2 days 1–3 or topotecan 1 mg/m2 days 1–5 for a minimum of three 21-day cycles. The primary endpoint of ORR was 38% for the amrubicin arm and 21% in the topotecan arm.[35] In sensitive relapse, the ORRs for amrubicin and topotecan were 53% and 21%, and in refractory relapse, 17% and 0%, respectively. There were no significant advantages of either therapy in median PFS and OS. Neutropenia was severe for those treated with amrubicin, with 79% of the patients experiencing grade 4 neutropenia and 14% of the patients experiencing febrile neutropenia. Moreover, 1 treatment-related death was observed resulting from sepsis. Encouragingly, amrubicin has activity, particularly in chemotherapy-refractory relapse, which is notoriously difficult to treat. Results are limited by the small sample size but still warrant further evaluation in larger-scale trials.

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