A randomized phase II study comparing induction or consolidation chemotherapy with cisplatin-docetaxel, plus radical concurrent chemoradiotherapy with cisplatin-docetaxel, in patients with unresectable locally advanced non-small-cell lung cancer.
BACKGROUND
In stage III non-small-cell lung cancer (NSCLC), the role of systemic chemotherapy preceding or following concurrent chemo-radiotherapy (CT-RT) is unclear. We carried out a randomized phase II study to study the toxicity involved-field CT-RT with either induction or consolidation cisplatin-docetaxel (Taxotere).


METHODS
Patients were randomly assigned to receive two cycles of docetaxel (D) 75 mg/m(2) on day 1 and cisplatin (C) 40 mg/m(2) on days 1 and 2, either preceding (IND arm) or following (CON arm) concurrent CT-RT, where 66 Gy was delivered using involved-fields concurrent with weekly D 20 mg/m(2) and C 20 mg/m(2). Patients at higher risk for lung toxicity (V(20) > 35%) crossed over to IND arm. Seventy patients were needed to exclude grade (G)3-4 esophagitis in >25%.


RESULTS
Of the 70 eligible patients, 26 were treated in IND and 34 CON; five with V(20) >35% switched from CON to IND. The differences in G3-4 esophagitis observed (32/2% IND versus 21/3% CON) were not significantly different from the hypothesized 25% rate. Rates of G≥2 pneumonitis were similar, but IND arm had less G3-4 neutropenia. One-year survival was 63.2% [95% confidence interval (CI) 48.4% to 78.0%] and 65.5% (95% CI 48.2% to 82.8%) for the IND and CON arms, respectively.


CONCLUSIONS
Both study arms merit further testing in patients with limited volume stage III NSCLC.
Senan
S
S
Department of Radiation Oncology, VU Medical Center, Amsterdam, The Netherlands. Electronic address: s.senan@vumc.nl.
Cardenal
F
F
Department of Medical Oncology, Institut Catala d'Oncologia, Barcelona, Spain.
Vansteenkiste
J
J
Respiratory Oncology Unit, University Hospital Gasthuisberg, Leuven, Belgium.
Stigt
J
J
Isala Klinieken, Pulmonology, Zwolle, The Netherlands.
Akyol
F
F
Department of Radiation Oncology, Hacettepe University, Ankara, Turkey.
De Neve
W
W
Department of Radiation Oncology, Ghent University Hospital, Gent, Belgium.
Bakker
J
J
Medical Affairs and Clinical Operations, sanofi-aventis, Gouda, The Netherlands.
Dupont
J-M
JM
PRA-International, Paris, France.
Scagliotti
G V
GV
Department of Thoracic Oncology, San Luigi Hospital.
Ricardi
U
U
Department of Radiation Oncology, Ospedal San Giovanni Battista, University of Torino, Torino, Italy.
van Meerbeeck
J P
JP
Department of Thoracic Oncology, Ghent University Hospital, Gent, Belgium.
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy*; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D000077143:Docetaxel; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008175:Lung Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000532:radiotherapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome; D047368:Tumor Burden
D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin