Purpose: As locally advanced and inoperable non-small cell lung cancers still have a poor prognosis, the present phase II study focused on the administration of concomitant chemotherapy and radiotherapy and was aimed at increasing both local and metastatic controls.
Materials and methods: Thirty-nine patients (36 male and three female patients, mean age, 56 years) were included into the study. Ninety five percent of them had a good performance status (OMS status 0 or 1). The histopathological analysis showed the existence of squamous cell in 64% of the cases. There was one stage I tumor, nine stage IIIA tumors and 24 stage IIIB tumors. In two cases, the tumor stage was unknown. The duration of each cycle of the protocol was 3 weeks and included the administration of cisplatin (50 mg/m2 at d1 and d2) and fluorouracil (5-FU) (1 gr/m2 in continuous infusion at d1, d2, and d3), and external beam irradiation (20 Gy subdivided into 2 Gy-fractions that were administered from d1 to d12); the 3rd week was a resting period.
Results: The tolerance to the treatment was good. Fifteen per cent grade 3-4 leucopenia, 3% grade 3-4 thrombopenia and 15% grade 3-4 nausea with vomiting were observed. No serious esophagitis was recorded. Chemotherapy was completed in more than 90% of the cycles. An objective response was described in 56% of the cases, with only 3% of complete responses. However, evaluation was done on average 6 weeks after radiotherapy, at a time where post-irradiation fibrosis could hamper radiological assessment. Median survival and 2- and 3-year survivals were 11.4 months, 27% and 14%, respectively. The only significant prognostic factor was the OMS performance status index, while the radiological response was particularly non-predictive of survival. Failure patterns were analyzed in 20 patients and consisted of the following: local relapse only, six cases; metastatic relapse only, 13 cases; both local and metastatic relapse, one case.
Conclusion: The concomitant administration of 5-FU, cisplatin and external irradiation seems feasible in current clinical practice. Survival but not radiological response should be the only criteria to evaluate this type of association. Improvement in local control is not unlikely with this type of association.