ALTERNATED APPROACH WITH LOCAL IRRADIATION AND COMBINATION CHEMOTHERAPY INCLUDING CISPLATIN OR CARBOPLATIN PLUS EPIRUBICIN AND ETOPOSIDE ININTERMEDIATE STAGE NONSMALL CELL LUNG-CANCER

Background. Prognosis of unresectable non-small cell lung cancer (NSCL C) patients is disappointing; their median survival time does not exce ed 8-12 months. Recently, some authors reported an increased response rate and sometimes a prolonged survival for patients with intrathoraci c disease treated with local irradiation combined with cytotoxic drugs . Methods. Fifty-eight consecutive patients with Stage ILIA or IIIB NS CLC were enrolled in a randomized Phase II trial of alternated treatme nt composed of four courses of combination chemotherapy and three cycl es of local irradiation. Chemotherapy consisted of a randomly selected platinum compound (cisplatin [60 mg/m(2)] or carboplatin [300 mg/m(2) ]) intravenously (i.v.) on Day 1, epirubicin (50 mg/m(2)) i.v. on Day 1, and etoposide (100 mg/m(2)) i.v. on Days 1-3. A course of radiother apy consisted of 5 consecutive fractions (3 Gy per fraction, 1 fractio n per day) for a total dosage of 15 Gy per course. Each course of chem otherapy was alternated every 2 weeks with a course of irradiation so that the entire treatment was performed in 13 weeks, Results. Of the 5 8 patients, 53 were evaluable for response: 7 showed a complete clinic al remission, and 25 reached a partial response, giving an overall res ponse rate of 60% (95% confidence interval, 46%-74%). The tumors of fo ur patients who showed a complete or partial response subsequently wer e surgically resected, and the complete disappearance of any residual tumor cells was documented histologically in two of them. No differenc e in response was observed between cisplatin- (16 of 26 [62%]) and car boplatin-treated patients (16 of 27 [59%]), and no correlation was fou nd between response and either stage or histology. Patients enrolled i n the carboplatin arm experienced less severe leukopenia and vomiting than did those in the cisplatin arm. Median freedom from progression a nd overall survival time were 28 and 39 weeks, respectively. Patients who responded had a significantly longer median duration of survival ( 49 weeks) as compared to non-responders (15 weeks). Conclusions. The a lternated chemoradiotherapy treatment obtained a high response rate wi th substantial toxicity. This approach did not seem to improve the pro gnosis of patients significantly. In this setting, the administration of carboplatin intead of cisplatin appeared to be tolerated better by the patients.