Phase II multicenter trial with carboplatin and gemcitabine induction chemotherapy followed by radiotherapy concomitantly with low-dose paclitaxel and gemcitabine for stage IIIA and IIIB non-small cell lung cancer.
BACKGROUND
The optimal combination of concomitant radiotherapy (RT) and chemotherapy in stage III unresectable non-small cell lung cancer (NSCLC) remains unclear. The role of induction chemotherapy with carboplatin/gemcitabine regimen has not been established in stage III NSCLC.


METHODS
Forty-two stage III NSCLC patients, 41 assessable, with a median age of 60 years and good performance status, entered this trial between January 2003 and November 2004. They received carboplatin area under the curve 5 on day 1 and gemcitabine 1000 mg/m2 on days 1 + 8 every 3 weeks for two cycles, followed on day 50 by RT 60 Gy, concomitantly with paclitaxel 50 mg/m2 and gemcitabine 100 mg/m2 on days 1 + 8 every 3 weeks for two cycles.


RESULTS
After induction, the partial response (PR) was 73.1% and stable disease was 24.4%. Disease progressed in one patient. After RT and paclitaxel/gemcitabine, 22% achieved a complete response and 73% a PR, and 5% had disease progression. The median survival was 25 months, the 1-year survival rate was 73.2%, and the 2-year survival rate was 50.5%. During concomitant RT and chemotherapy, grade 3 neutropenia, thrombocytopenia, and anemia occurred in eight, three, and three patients, respectively, and grade 4 neutropenia and thrombocytopenia in one patient each. One patient developed an esophageal fistula and died shortly after, which was considered a grade 5 toxicity; one patient developed grade 4 interstitial pneumonitis, and three patients developed grade 3 esophagitis.


CONCLUSIONS
This regimen appears to be effective and was well tolerated. Further studies using this approach are warranted in patients with stage III NSCLC.
Hirsh
Vera
V
Division of Medical Oncology, Department of Medicine, McGill University Health Center, Montreal, Quebec, Canada. vera.hirsh@muhc.mcgill.ca
Soulieres
Denis
D
Duclos
Marie
M
Faria
Sergio
S
Del Vecchio
Pierre
P
Ofiara
Linda
L
Ayoub
Jean-Pierre
JP
Charpentier
Danielle
D
Gruber
James
J
Portelance
Lorraine
L
Souhami
Luis
L
D000230:Adenocarcinoma / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D018287:Carcinoma, Large Cell / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy / Q000628:therapy*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy; D003131:Combined Modality Therapy; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy / Q000628:therapy*; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage; D011379:Prognosis; D011446:Prospective Studies; D011879:Radiotherapy Dosage; D012074:Remission Induction; D015996:Survival Rate; D016896:Treatment Outcome; D000093542:Gemcitabine
D003841:Deoxycytidine; D016190:Carboplatin; D017239:Paclitaxel; D000093542:Gemcitabine