Irinotecan plus gemcitabine vs irinotecan for the second-line treatment
of patients with advanced non-small-cell lung cancer pretreated with
docetaxel and cisplatin: a multicentre, randomised, phase II study
To compare irinotecan (CPT-11) + gemcitabine vs CPT-11 alone as
second-line treatment for patients with advanced non-small cell lung
cancer (NSCLC) progressing after docetaxel-cisplatinum- based therapy. A
total of 147 evaluable, pretreated patients, with NSCLC, received either
gemcitabine (1000 mg m(-2), days 1 and 8) + CPT-11 (300 mg m(-2), day 8)
(Group A, n = 76) or CPT-11 (300 mg m(-2), day 1) (Group B, n = 71),
every 3 weeks. All patients were evaluable for response and toxicity.
The objective response rate was 18.4% (95% CI: 9.71-27.14%) and 4.2%
(95% CI: 0-8.90%) (P = 0.009) for groups A and B, respectively. No
significant differences between the two groups in terms of the median
duration of response, time to tumour progression, overall survival and
1-year survival were observed. The CPT-11/gemcitabine regimen
significantly improved the patients’ quality of life (’general mood
today’ (P = 0.014), ‘coughing’ (P = 0.003) and ‘intensity of symptoms’
(P = 0.034)) compared with CPT-11. More cycles had to be delayed (P =
0.001) and required prophylactic growth factor support (P = 0.001) in
Group A than B. Three (3.9%) patients in Group A and eight (11.3%) in
Group B developed febrile neutropenia (P = 0.09); one patient died of
sepsis in each group. Three additional (Group A, n = 1; Group B, n 2)
treatment-related deaths were observed. Grade 3-4 haematologic toxicity
was comparable in the two groups except anaemia (P = 0.03 in favour of
CPT-11). Other nonhaematologic toxicities were mild and similar in the
two groups. CPT-11 + gemcitabine resulted in a higher response rate and
better control of disease-related symptoms than CPT-11 alone, but
without any improvement in the overall survival
