Phase II trial with carboplatin and bendamustine in patients with extensive stage small-cell lung cancer.
BACKGROUND
Bendamustine is an alkylating agent with hybrid activity and proven efficacy in small-cell lung cancer associated with a favorable toxicity rate. This phase II study of carboplatin/bendamustine was conducted to evaluate the efficacy of this combination in patients with extensive disease small-cell lung cancer (ED-SCLC).


METHODS
Fifty-six untreated patients with ED-SCLC were enrolled. Their median age was 63 years. Sixty-seven percent of patients were male and 18% had a World Health Organization performance status of 2. Bendamustine was administered as a 30- to 60-minute infusion at a dose of 80 mg/m2 on days 1 and 2, and carboplatin was given at an area under the curve of 5 on day 1 of a 21-day cycle.


RESULTS
Fifty-five patients were assessable for response and toxicity. The overall response rate was 72.7% (95% confidence interval: 59%-84%), with one complete remission (1.8%). The median time to progression was 5.2 months (95% confidence interval: 4.2-5.6). At the time of evaluation, 71% of the patients had died. The median survival time reached 8.3 months (95% confidence interval: 6.6-9.9). The major toxicity of this regimen was myelosuppression, including grade 3 or 4 neutropenia (46%), thrombopenia (26%), anemia (15%), and infections (11%). Toxic death was recorded in two patients (3.6%).


CONCLUSIONS
The carboplatin/bendamustine regimen is a well-tolerated cytostatic combination in ED-SCLC with activity comparable with that of other platinum-based regimens. Further investigations, such as a phase III trial, are currently planned.
Köster
Wolf
W
Department of Medical Oncology and Hematology, Center of Palliative Care, Kliniken Essen-Mitte, Essen, Germany. wkoester@kliniken-essen-mitte.de
Heider
Andrea
A
Niederle
Norbert
N
Wilke
Hansjochen
H
Stamatis
Georgios
G
Fischer
Jürgen R
JR
Koch
Jens A
JA
Stahl
Michael
M
D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D000069461:Bendamustine Hydrochloride; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality* / Q000473:pathology; D016001:Confidence Intervals; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007262:Infusions, Intravenous; D053208:Kaplan-Meier Estimate; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality* / Q000473:pathology; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009367:Neoplasm Staging; D009588:Nitrogen Mustard Compounds / Q000008:administration & dosage / Q000009:adverse effects; D018579:Patient Selection; D011336:Probability; D018570:Risk Assessment
D009588:Nitrogen Mustard Compounds; D000069461:Bendamustine Hydrochloride; D016190:Carboplatin