Induction therapy with paclitaxel and carboplatin followed by hyperfractionated radiotherapy plus weekly concurrent chemotherapy and subsequent consolidation therapy in unresectable locally advanced non-small-cell lung cancer.
OBJECTIVE
The purpose of this pilot study was to determine the safety and feasibility of a complete integrated approach, including induction chemotherapy with carboplatin/paclitaxel followed by accelerated hyperfractionated radiotherapy with concurrent chemotherapy, and then by consolidation chemotherapy for locally advanced stage III non-small cell lung carcinoma.


METHODS
Systemic doses of carboplatin AUC 6 and paclitaxel (200 mg/m2), 3 weeks out of 4, were planned as induction and consolidation chemotherapy. Weekly carboplatin AUC of 2 plus paclitaxel (50 mg/m2) were given during thoracic radiotherapy.


RESULTS
Eighteen patients were enrolled: 10 were evaluated at the end of chemoradiation and 8 received consolidation chemotherapy. On an intent-to-treat basis, 55% of patients achieved a response after induction therapy, whereas chemoradiation and consolidation therapy increased the response rate by 33% and 16%, respectively. No patient experienced grade > 3 acute hematologic toxicity during systemic-dose chemotherapy. With the exception of one episode of a severe cardiac adverse event, non-hematologic toxicity was similarly tolerable. Severe acute adverse events observed during concurrent chemoradiation were mainly represented by esophagitis, resulting in interruption of the radiotherapy in 25% of patients. More notably, only one patient experienced serious non-hematologic late toxicity.


CONCLUSIONS
Although the present approach seemed feasible, our data did not support any possible advantage in favor of this three-phase integrated treatment, and therefore the design will not be investigated in a subsequent phase II study.
Cortesi
Enrico
E
Medical Oncology B, Policlinico Umberto I Hospital, "La Sapienza" University, Rome, Italy.
Moscetti
Luca
L
Nelli
Fabrizio
F
De Marinis
Filippo
F
De Paula
Ugo
U
Bangrazi
Caterina
C
Migliorino
Maria Rita
MR
Donato
Vittorio
V
D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage*; D002289:Carcinoma, Non-Small-Cell Lung / Q000150:complications / Q000628:therapy*; D019583:Dose Fractionation, Radiation; D004941:Esophagitis / Q000209:etiology; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000009:adverse effects / Q000379:methods; D017239:Paclitaxel / Q000008:administration & dosage*; D010865:Pilot Projects; D012074:Remission Induction / Q000379:methods
D016190:Carboplatin; D017239:Paclitaxel