Oral vinorelbine and cisplatin with concomitant radiotherapy in stage III non-small cell lung cancer (NSCLC): A feasibility study

Background: Concurrent chemoradiotherapy has improved survival in
inoperable stage III non-small cell lung cancer (NSCLC). This phase
I trial was performed in order to establish a dose recommendation
for oral vinorelbine in combination with cisplatin and simultaneous
radiotherapy. Patients and Methods: Previously untreated patients
with stage IIIB NSCLC received concurrent chemoradiotherapy with 66
Gy and 2 cycles of cisplatin and oral vinorelbine which was
administered at 3 different levels (40, 50 and 60 mg/m(2)). This
was to be followed by 2 cycles of cisplatin/vinorelbine oral
consolidation chemotherapy. The study goal was to determine the
maximal recommended dose of oral vinorelbine during concurrent
treatment. Results: 11 stage IIIB patients were entered into the
study. The median radiotherapy dose was 66 Gy. Grade 3-4 toxicity
included neutropenia, esophagitis, gastritis and febrile
neutropenia. The dose-limiting toxicity for concurrent
chemoradiotherapy was esophagitis. 9 patients received
consolidation chemotherapy, with neutropenia and
anemia/thrombocytopenia grade 3 being the only toxicities. The
overall response was 73%. Conclusion: Oral vinorelbine 50 mg/m(2)
(days 1, 8, 15 over 4 weeks) in combination with cisplatin 20 mg/m2
(days 1-4) is the recommended dose in combination with radiotherapy
(66 Gy) and will be used for concurrent chemoradiotherapy in a
forthcoming phase III trial testing the efficacy of consolidation
chemotherapy in patients not progressing after chemoradiotherapy.