Randomized phase III PITCAP trial and meta-analysis of induction chemotherapy followed by thoracic irradiation with or without concurrent taxane-based chemotherapy in locally advanced NSCLC.
Chemo-radiotherapy is standard of care in the treatment of unresectable stage III NSCLC. We aimed at assessing whether the addition of concurrent taxane-chemotherapy to thoracic irradiation following chemotherapy was able to improve treatment outcome.



In PITCAP trial, patients with unresectable stage III NSCLC were randomized to receive 2 cycles of platinum-paclitaxel followed by 60-61.2Gy thoracic irradiation (control arm) or by same radiotherapy with concomitant weekly paclitaxel (experimental arm). A literature-based meta-analysis including all studies with same design was also performed.



At the time of the second interim analysis, when 151 patients were randomized, accrual was terminated. With a median follow-up of 6.1 years, median survival was 13.2 vs 15.1 months, with a 3-year survival rate of 19.5 vs 21.2% in the control and experimental arm, respectively (HR: 0.97; 95% CI 0.69-1.36; p=0.845). Treatment toxicity was manageable in both arms. The meta-analysis of 5 trials (n=866) confirmed the lack of a meaningful effect on 1-year overall survival of a taxane added concurrently to radiotherapy.



These results do not support a meaningful survival benefit with the addition of single agent taxane given concurrently to radiotherapy after platinum-based induction in locally advanced NSCLC.
Medical Oncology Unit, Sant'Orsola-Malpighi University Hospital, Bologna, Italy.
Andrea
A
Ardizzoni
Medical Oncology Unit, University Hospital, Parma, Italy. Electronic address: mtiseo@ao.pr.it.
Marcello
M
Tiseo
Clinical Trials Coordinating Center, Istituto Toscano Tumori, University Hospital Careggi, Firenze, Italy.
Luca
L
Boni
Department of Oncology, University of Torino, Orbassano, Torino, Italy.
Massimo
M
Di Maio
Department of Oncology, University of Torino, Orbassano, Torino, Italy.
Lucio
L
Buffoni
Department of Oncology, Medical Oncology Unit, University Hospital, Udine, Italy.
Ornella
O
Belvedere
Medical Oncology Unit A, IRCCS San Martino University Hospital - IST National Cancer Research Institute, Genova, Italy.
Francesco
F
Grossi
Respiratory Oncology Section, I Internal Medicine Department, IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.
Vito
V
D'Alessandro
Division of Thoracic Oncology, European Institute of Oncology (IEO), Milan, Italy.
Filippo
F
de Marinis
Division of Oncologic Pneumology, Mariano Santo Hospital, Cosenza, Italy.
Santi
S
Barbera
Academic Unit of Medical Oncology, IRCCS San Martino University Hospital - IST National Cancer Research Institute, Genova, Italy.
Cinzia
C
Caroti
Department of Clinical and Experimental Oncology, Medical Oncology 2, Istituto Oncologico Veneto IRCCS, Padova, Italy.
Adolfo
A
Favaretto
Medical Oncology Unit, San Gerardo Hospital, Monza, Italy.
Diego
D
Cortinovis
Radiotherapy Unit, Istituto Nazionale Tumori Fondazione G. Pascale, Napoli, Italy.
Brunello
B
Morrica
Department of Internal Medicine, IRCCS San Martino University Hospital - IST National Cancer Research Institute, Genova, Italy.
Lucia
L
Tixi
Department of Oncology, Radiotherapy Unit, University Hospital, Udine, Italy.
Tino
T
Ceschia
Radiotherapy Department, IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.
Salvatore
S
Parisi
Department of Oncology, Radiation Oncology, University of Torino, Italy.
Umberto
U
Ricardi
Radiotherapy Unit, Galliera Hospital, Genova, Italy.
Andrea
A
Grimaldi
Radiotherapy Department, Istituto Oncologico Veneto IRCCS, Padova, Italy.
Lucio
L
Loreggian
Radiotherapy and Radiosurgery Department, Humanitas Research Hospital, Rozzano, Milano, Italy.
Pierina
P
Navarria
Pneumologie, Medizinische Klinik Innenstadt, University of Munich, Munich, Germany.
Rudolf M
RM
Huber
University of Pittsburgh Cancer Institute, Pittsburgh, PA, United States.
Chandra
C
Belani
Norwegian Radium Hospital, Oslo, Norway.
Paal Fr
PF
Brunsvig
Department of Oncology, University of Torino, Orbassano, Torino, Italy.
Giorgio Vittorio
GV
Scagliotti
Radiotherapy Unit, La Spezia Hospital, Italy.
Tindaro
T
Scolaro
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D001952:Bridged-Ring Compounds / Q000008:administration & dosage* / Q000627:therapeutic use; D016190:Carboplatin / Q000008:administration & dosage* / Q000627:therapeutic use; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000532:radiotherapy*; D003131:Combined Modality Therapy / Q000379:methods*; D005260:Female; D006801:Humans; D060828:Induction Chemotherapy; D008297:Male; D015201:Meta-Analysis as Topic; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage* / Q000627:therapeutic use; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage* / Q000627:therapeutic use; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D001952:Bridged-Ring Compounds; D043823:Taxoids; C080625:taxane; D016190:Carboplatin; D017239:Paclitaxel
Chemotherapy; Concurrent treatment; NSCLC; Radiotherapy; Stage III