OBJECTIVE:
The primary objective of the study presented here was to determine the efficacy and the toxicity profile of a biweekly regimen of paclitaxel plus gemcitabine in patients with small cell lung cancer
previously treated with a combination of etoposide and platinum based chemotherapy (sensitive and refractory/resistant). The combination of gemcitabine and paclitaxel is particularly valuable
because of the different mechanisms of action of each drug and their non-overlapping toxicities.
METHODS:
A total of 40 patients were evaluated with the following characteristics: median age 57.5 years (range 39-77), male 34 (85%)/female 6 (15%), ECOG 0/1/2: 4(10%)/25(62.5%)/11(27.5%). Four patients
(10%) were platinum-sensible, 31 (77.5%) were platinum-resistant (progression within 3 months since the last course) and 5 (12.5%) were platinum-refractory (progression during the first line with
platinum-etoposide based chemotherapy). Treatment consisted of paclitaxel (80 mg/m2) and gemcitabine (1250 mg/m2) on days 1 and 15 of a 4 week cycle. Treatment was held until disease progression or
unacceptable toxicity.
RESULTS:
Patients received a median of 2 cycles (range 1-6). Tumor control was reported in 13 patients (32.5%) with 6 partial responses (15%) and 7 stable diseases (17.5%). Median progression free survival
was 8 weeks (95% CI 5.67 – 10.32) and median overall survival 13 weeks (95% CI 0.00 – 27.35). Those patients with ECOG 2 had a significant shorter overall survival compared with ECOG 0
and 1 (5 weeks versus 28 and 19 weeks, p = 0.035). Toxicity profile was mild: neurotoxicity grade 2 (20%) and grade 3 (2.5%), asthenia grade 2 (30%) and grade 3 (7.5%), thrombocytopenia grade 3
(2.5%) and grade 4 (10%), anemia grade 3 (5%) and grade 4 (2.5%) and one febrile neutropenia. There were two toxicity related deaths (both of them in ECOG2 patients).
CONCLUSIONS:
Paclitaxel plus gemcitabine given on days 1 and 15 of a 4 week cycle is a well tolerated and an active combination regimen in pretreated patients with small-cell lung cancer and good performance
status.