Split course radiation with concurrent vinorelbine and cisplatin in locally advanced non-small cell lung cancer. A phase II study.

Purpose: Recent results coming from large randomized trials suggest that for locally advanced non-small cell lung cancer (NSCLC), integration of chemotherapy (CT) with irradiation (RT) should be concurrent rather than sequential. This study aimed at evaluating the actually delivered RT and CT dose intensities (DI), along with the toxicity and efficacy of a split course RT program with concurrent CT.

Patients And Methods: From October 2000 to September 2002, 24 patients with histologically or cytologically documented NSCLC were included. Patients' characteristics were as follows: males/females=22/2, median age=59 years, stage IIIB/IIIA=22/2 patients, ECOG PS 0-1=15 (62%) and PS 2=9 (38%).

Histology: adenocarcinoma/ squamous cell/large cell/unclassified 10/6/1/7, respectively. Four cycles of vinorelbine (VNB) 25 mg/m(2) and cisplatin (CDDP) 40 mg/m(2) on days 1+8 were administered (days 1,8,22,29,57,64,78,85). Concurrent with the second CT cycle, RT (2 courses of 30 Gy separated by a 2-week break) was delivered, with a plan to achieve a total dose of 60 Gy, with a fractionation schedule of 2 Gy/day/5 days weekly.

Results: The intended RT dose was delivered to 21 (88%) patients with a relative DI of 0.93. Nineteen (79%) patients received more than 3 CT cycles. The relative DI for VNB and CDDP were 0.88 and 0.83, respectively. During treatment 3 (13%) patients experienced WHO grade 3-4 hematologic toxicity while ECOG grade 3 esophagitis was recorded also in 3 patients. At the end of treatment 14 (58%) patients achieved an objective response (2 complete - CR and 12 partial response - PR), while 8 (33%) patients had stable disease (SD) and 2 (8%) progressive disease (PD). After a median follow up of 15 months (range 3-26), 15 (62%) patients relapsed. There were 8 (33%) patients with local relapse and 7 (29%) with distant metastases. The median progression free (PFS) and overall survival (OS) were 10 (range 2-24) and 15 (range 5-24) months, respectively, with an estimated 1 and 2-year survival rates of 55% and 10%, respectively.

Conclusion: Our concurrent schedule allows for good CT and RT DI, with low associated toxicities. The efficacy data are considered promising, taking into account the high proportion of stage IIIB patients evaluated.