[Concurrent split-course chemotherapy and radiotherapy for unresectable stage III non-small cell lung cancer: preliminary results of a Phase II study].
OBJECTIVE
We initiated at Hospital de Mulhouse a prospective phase II study to assess a split-course concurrent radiochemotherapy in locally advanced non-small cell lung cancer.


METHODS
From March 1996 to December 1997, 28 patients were included in our study. All patients had a stage III cancer. The chemotherapy scheduled included vinorelbine (20 mg/m2/d, d1 and d5), cisplatin (20 mg/m2/d, from d1 to d5), and 5-Fluorouracil (350 mg/m2/d, from d1 to d5 by continuous infusion). The planned irradiation dose was 12.5 Gy per week with one daily fraction of 2.5 Gy from d1 to d5. Cycles were repeated every four weeks, for four cycles (50 Gy). Patients with a partial or complete response were proposed a fifth cycle.


RESULTS
Of the 28 patients of the study, only 27 were analysed; one patient had a metastatic disease at diagnosis. Major hematologic toxicity occurred in 26% of the patients. One to five cycles of chemoradiotherapy were administrated per patient (median: four). Four patients had received fewer than three cycles and their responses were not assessable. Of the 23 patients assessed, 12 responses (52%) were observed, three CR (13%) and nine PR (39%). Median follow-up was 14 months, and median survival 13.5 months. One- and two-year survival rates were respectively 63% and 14%. Local control rates was 11%, and 44% of the patients had a metastatic evolution.


CONCLUSIONS
Very preliminary results of this phase II study are disappointing, and quite inferior to the published results using chemoradiotherapy with conventional or hyperfractionated radiotherapy. Hematologic toxicity is restrictive. This type of chemoradiotherapy cannot be recommended.
Benchalal
M
M
Service d'oncoradiothérapie de Mulhouse, hôpital du Hasenrain, France.
Salze
P
P
Bombaron
P
P
Bourderont
D
D
Neidhardt
A C
AC
Maitre
A M
AM
Pignol
J P
JP
Lambert
J
J
Baumann
J
J
Sizaret
O
O
Newinger
G
G
Noirclerc
M
M
Sabountchi
M
M
Zipper
J M
JM
Prevot
G
G
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000532:radiotherapy*; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D019583:Dose Fractionation, Radiation; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
D014747:Vinblastine; D002945:Cisplatin; D000077235:Vinorelbine; D005472:Fluorouracil