A multicentre phase II trial of cabazitaxel in patients with advanced non-small-cell lung cancer progressing after docetaxel-based chemotherapy.
Cabazitaxel, a semisynthetic microtubule inhibitor, has shown antitumour activity in models resistant to paclitaxel and docetaxel, and it has been approved for the treatment of docetaxel-resistant prostate cancer. We investigated its activity in patients with advanced non-small-cell lung cancer (NSCLC) progressing under or after docetaxel-based regimens.



Patients with locally advanced unresectable or metastatic NSCLC, with an Eastern Cooperative Oncology Group performance status of 0-2, were enrolled; patients had to have received up to two prior chemotherapy regimens for the treatment of advanced disease, including one docetaxel-containing regimen. Treatment consisted of cabazitaxel (25 mg m(-2) intravenously, every 21 days) until disease progression. The primary end point was the overall response rate.



Among the 46 evaluable patients, 28.3% had squamous cell carcinoma and 54.3% had adenocarcinoma. Eight (17.4%) patients had received one and 38 (82.6%) two prior chemotherapy regimens. Treatment compliance was 95%; 26 (16%) cycles were delayed because of toxicity, (n=13) and dose reduction was required in 6 (13%) patients because of haematologic toxicity. Six (13%) patients achieved a partial response and 17 (37.0%) stable disease. The median progression-free survival and overall survival were 2.1 (95% confidence interval (CI): 1.0-3.2) and 7.4 (95% CI: 5.2-9.6) months, respectively. Grade 4 adverse events included neutropenia (n=8; 17%), febrile neutropenia (n=6; 13%) and thrombocytopenia (n=3; 6.5%). There was one treatment-related death.



Cabazitaxel exhibits activity in NSCLC patients pre-treated with docetaxel-based chemotherapy with a substantial but manageable toxicity profile. The drug merits further evaluation in this indication.
Hellenic Oncology Research Group (HORG), 55 Lombardou Street, Athens 11470, Greece.
A
A
Kotsakis
Hellenic Oncology Research Group (HORG), 55 Lombardou Street, Athens 11470, Greece.
A
A
Matikas
Hellenic Oncology Research Group (HORG), 55 Lombardou Street, Athens 11470, Greece.
F
F
Koinis
Hellenic Oncology Research Group (HORG), 55 Lombardou Street, Athens 11470, Greece.
N
N
Kentepozidis
Hellenic Oncology Research Group (HORG), 55 Lombardou Street, Athens 11470, Greece.
I I
II
Varthalitis
Hellenic Oncology Research Group (HORG), 55 Lombardou Street, Athens 11470, Greece.
V
V
Karavassilis
Hellenic Oncology Research Group (HORG), 55 Lombardou Street, Athens 11470, Greece.
Ep
E
Samantas
Hellenic Oncology Research Group (HORG), 55 Lombardou Street, Athens 11470, Greece.
P
P
Katsaounis
Hellenic Oncology Research Group (HORG), 55 Lombardou Street, Athens 11470, Greece.
E K
EK
Dermitzaki
Hellenic Oncology Research Group (HORG), 55 Lombardou Street, Athens 11470, Greece.
D
D
Hatzidaki
Hellenic Oncology Research Group (HORG), 55 Lombardou Street, Athens 11470, Greece.
D
D
Mavroudis
Hellenic Oncology Research Group (HORG), 55 Lombardou Street, Athens 11470, Greece.
V
V
Georgoulias
D000230:Adenocarcinoma / Q000188:drug therapy; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D018287:Carcinoma, Large Cell / Q000188:drug therapy; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy; D018572:Disease-Free Survival; D000077143:Docetaxel; D019008:Drug Resistance, Neoplasm; D057915:Drug Substitution; D004417:Dyspnea / Q000139:chemically induced; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006115:Greece; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D053208:Kaplan-Meier Estimate; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D000077143:Docetaxel; C552428:cabazitaxel