Compliance with adjuvant chemotherapy in non-small cell lung cancer. The experience of a single institution evaluating a cohort of 356 patients.

PURPOSE: To evaluate the patient compliance with adjuvant chemotherapy (CT) following radical surgery for non-small cell lung cancer (NSCLC), and to identify the potential confounding factors affecting this particular aspect. PATIENTS AND METHODS: We retrospectively evaluated a series of 356 consecutively treated NSCLC patients at a single institution during 1994-2003. All patients had macroscopic and microscopic radical resection of the primary tumor, with or without mediastinal node dissection or sampling, had received at least one adjuvant CT cycle, with or without postoperative irradiation (RT). CT was planned to be believed for 6 cycles. The following schedules were used: cisplatin (CDDP) 60 mg/m(2), cyclophosphamide 600 mg/m(2) and epirubicin 60 mg/m(2) on day 1 every 21 days (16%);etoposide 120 mg/m(2) and CDDP 30 mg/m(2), on days 1-3, every 21 days (68%); other platinum-based doublets (16%). A multivariate analysis, for a target of 4 and 6 cycles was performed in order to evaluate the potential impact on the patient compliance of the following categories: age, sex (male vs. female), extent of surgery (pneumectomy vs. lesser resection), stage (I,II vs. III), RT(delivered or not) and patient residence (local vs. remote). RESULTS: One hundred and seventy-nine (50%) patients completed all 6 cycles, while 299 (84%) received at least 4 cycles. The median number of administered cycles was 5. For a target of 4 cycles none of the investigated variables had any significant impact. A significant impact on compliance for 6 cycles was recorded for age (OR 0.97, 95% CI 0.95-0.99, p=0.01) and extent of surgery (OR 0.54, 95% CI 0.33-0.87, p=0.01) CONCLUSION: Using the above mentioned combinations, the patient compliance with adjuvant CT was good, with 84% receiving at least 4 and 50% all 6 cycles. The median number of cycles was 5. For a target of 4 cycles none of the investigated variables had a significant impact. For a longer CT duration, age and extent of surgery were correlated with a lower compliance.

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.