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Platinum-Etoposide Chemotherapy in Elderly Patients With Small-Cell Lung Cancer: Results of a Randomized Multicenter Phase II Study Assessing Attenuated-Dose or Full-Dose With Lenograstim Prophylaxis—A Forza Operativa Nazionale Italiana Carcinoma Polmonare and Gruppo Studio Tumori Polmonari Veneto (FONICAP-GSTPV) Study

From the Oncologia Medica Asl 18, Alba-Bra; Divisione di Pneumologia, Azienda Ospedaliera S. Anna, Como; Divisione di Pneumologia Oncologica, Presidio Ospedaliero Mariano Santo, Cosenza; Oncologia Medica & Centro Trials, Istituto Nazionale per la Ricerca sul Cancro, Genova; Oncologia Medica, Azienda Ospedaliera, Livorno; Oncologia Medica, Azienda Ospedaliera C. Poma, Mantova; Oncologia Medica, Azienda Ospedaliera, Padova; Oncologia Medica, Azienda Ospedaliera Castello, Venice; Divisione di Pneumologia I, Azienda Opsedaliera Cervello, Palermo; Fisiopatologia Respiratoria e Oncologia Medica, Azienda Ospedaliera, Parma; Oncologia Medica, Azienda Ospedaliera S. Chiara, Pisa; Broncopneumologia, Azienda Ospedaliera S. Camillo-Forlanini, Rome, Italy

Address reprint requests to Andrea Ardizzoni, MD, Medical Oncology, Parma University Hospital, Via Gramsci 14, 43100 Parma, Italy; e-mail: aardizzoni{at}ao.pr.it

PURPOSE: Small-cell lung cancer (SCLC) is increasingly diagnosed in elderly patients, who are at higher risk of treatment-related morbidity and mortality. We conducted a randomized two-stage phase II study to assess the therapeutic index of two different platinum/etoposide regimens, attenuated-dose (AD) and full-dose (FD) plus prophylactic lenograstim.

PATIENTS AND METHODS: SCLC patients older than 70 years were randomized to receive four courses of cisplatin 25 mg/m² on days 1 and 2, and etoposide 60 mg/m² on days 1, 2, and 3 every 3 weeks (AD); or cisplatin 40 mg/m² on days 1 and 2, and etoposide 100 mg/m² on days 1, 2, and 3 every 3 weeks, plus lenograstim 5 mg/kg days 5 through 12, every 3 weeks (FD). A combined primary end point named therapeutic success (TS), which took into account activity, toxicity, and compliance, was used.

RESULTS: Ninety-five patients were enrolled. Seventy-five percent and 72% of the patients in the AD and FD arms, respectively, completed the treatment as per protocol. Response rate was 39% and 69% in the AD and FD arms, respectively, and 1-year survival probability was 18% and 39%, respectively. Treatment was well tolerated in both groups, with no grade 3 to 4 myelotoxicity in the AD arm, and 12% myelotoxicity in the FD arm. Overall, the observed TSs were 10 (36%) of 28 patients and 42 (63%) of 67 patients for AD and FD treatments, respectively.

CONCLUSION: In elderly patients with SCLC a full-dose cisplatin/etoposide regimen combined with prophylactic lenograstim is active and feasible, while attenuated doses of the same regimen are associated with a poor therapeutic outcome.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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