P2.02-032 Induction Histology-Based Combination Chemotherapy for Elderly Patients with Inoperable Non-Small Cell Lung Cancer (NSCLC)

Abstract

SABR is an acceptable treatment of elderly patients with inoperable stage I-II NSCLC; for the stage III, sequential chemoradiotherapy may be appropriate, since it is better tolerated than concurrent chemoradiotherapy. In a prospective phase II not randomized study, patients aged 70 years or more with inoperable stage IIIA and IIIB histologically confirmed squamous cell carcinoma (SCC) or adenocarcinoma NSCLC and ECOG performance status (PS) 0-2, were treated with 3 cycles of induction chemotherapy according to their histology followed by definitive radiotherapy or possible surgery in selected cases. Chemotherapy regimens included: carboplatin at AUC 5 i.v. plus gemcitabine 1000 mg/mq i.v. on days 1,8 or pemetrexed 500 mg/mq i.v. every 21 days in patients with squamous or adenocarcinoma, respectively. Primary endpoint was activity as defined by the overall response rates (ORR) following induction chemotherapy and overall survival (OS); secondary endpoints included feasibility outcome (i.e., toxicity, rate of definitive radiotherapy, chemotherapy dose reduction or withdrawal) and progression-free survival (PFS). Twenty-seven patients, 23 males, 4 females, with a median age of 74 years (range, 70-80), PS=0/1 in 9/15 (33/56%) or 2 in 3 (11%) and median of 2 (range, 0-5) active comorbidities requiring medical treatment were treated. Fourteen patients (52%) had an adenocarcinoma and were treated with carboplatin and pemetrexed, 13 a SCC (42%) with carboplatin and gemcitabine. Eight patients (30%) had a stage IIIA, 19 patients (70%) a stage IIIB. The median cycle of chemotherapy was 3 (range, 1-4). Dose reduction or withdrawal was required in 2 and 3 patients, respectively (18%). ORR was 46% (in 12 of 26 assessable patients); 5 patients with a SCC (42%) and 7 patients with an adenocarcinoma (50%). SD and PD were reported in 4 (15%) and 10 (38%) patients, respectively. Twelve patients (44%) were subsequently treated with radiotherapy, 8 (42%) with stage IIIB and 4 (50%) with stage IIIA. Two patients (7%) with stage IIIA disease underwent lobectomy. With a median follow-up of 10.2 months, 9 patients (33%) were alive and progression-free; median OS and PFS data will be shown. G1-G2 neutropenia, asthenia, anemia, nausea/vomiting and diarrhea were the most frequent toxicity observed in 3 10% of patients and up to 45% for neutropenia. G3-4 neutropenia, asthenia, thrombocytopenia and fever was reported in one patient each (4%), G3 anemia in 2 patients. In a broad elderly NSCLC population induction histology-based chemotherapy seems to be active and feasible in selected patients.