TY - JOUR
TI - Two different schedules of irinotecan (CPT-11) in patients with advanced
colorectal carcinoma relapsing after a 5-fluorouracil and leucovorin
combination. A randomized study
AU - Tsavaris, N
AU - Ziras, N
AU - Kosmas, C
AU - Giannakakis, T
AU - Gouveris,
AU - P
AU - Vadiaka, M
AU - Dimitrakopoulos, A
AU - Karadima, D
AU - Rokana, S
AU - and Papalambros, E
AU - Papastratis, G
AU - Margaris, H
AU - Tsipras, H and
AU - Polyzos, A
JO - Cancer Chemotherapy and Pharmacology
PY - 2003
VL - 52
TODO - 6
SP - 514-519
PB - Springer-Verlag
SN - 0344-5704, 1432-0843
TODO - 10.1007/s00280-003-0659-z
TODO - irinotecan (CPT-11); colorectal cancer; chemotherapy
TODO - Purpose. To evaluate the efficacy and safety of irinotecan as
second-line treatment in patients with advanced colorectal cancer (ACC)
failing or relapsing after 5-fluorouracil (5-FU) plus leucovorin (LV)
standard chemotherapy. <LF>Patients and methods. Irinotecan was randomly
administered in two different schedules (once every 3 weeks, and every
10 days) in patients failing prior 5-FU plus LV. Patients were
randomized to two treatment groups: group A received irinotecan 350
mg/m(2) every 21 days and group B received irinotecan 175 mg/m(2) days 1
and 10 every 21 days. Results. Group A comprised 60 patients: 34 male/26
female, median age 64 years (range 48-70 years), and median Karnofsky
performance status (PS) 90. Their metastatic sites included liver
(n=47), lymph nodes (n=27), lung (n=14), abdomen (n=14), pelvis (n=8),
‘other’ (n=2), and local recurrence (n=12). Group B comprised 60
patients: 36 male/24 female, median age 62 years (46-70 years), and
median PS 90. Their metastatic sites included liver (n=49), lymph nodes
(n=29), lung (n=17), abdomen (n=16), pelvis (n=11), ‘other’ (n=2), and
local recurrence (n=13). Group A showed the following responses:
complete response (CR) 2, partial response (PR) 12, stable disease (SD)
21, progressive disease (PD) 26, overall response rate (ORR) 23%, tumor
growth control 58%. Group B showed the following responses: CR 1, PR
14, SD 22, PD 23; ORR 25%; tumor growth control 62%. Toxicities
included acute cholinergic syndrome (group A 53%, group B 19%;
P<0.0001), late-onset diarrhea grade 1/2 (group A 21%, group B 46%)
and grade 3/4 (group A 41%, group B 66%; P<0.0001), nausea and
vomiting grade 1/2 (group A 34%, group B 59%) and grade 3/4 (group A
30%, group B 12%; P<0.0001), neutropenia grade 3/4 (group A 27%,
group B 28%; P<0.03), with febrile neutropenia seen in only four
patients in group A, anemia grade more than 2 (group A 28%, group B
12%; P<0.05), asthenia grade more than 3 (group A 24%, group B 18%;
P<0.001), and alopecia grade more than 3 (group A 40%, group B 34%;
P<0.2). Conclusions. The present study indicates that, in patients with
ACC who have relapsed after 5-FU plus LV, the administration of
irinotecan fractionated into two doses every 21 days yields a similar
efficacy to, but a much lower incidence of toxicity than, the same total
dose of irinotecan administered once every 21 days.
ER -