Abstract
The aim of this study was to evaluate feasibility and toxicity of escalating doses of epirubicin and paclitaxel plus fixed dose of etoposide and to define the activity of the triplet in extensive disease small-cell lung cancer. Thirteen patients entered the phase I study: the maximum tolerated doses were epirubicin (EpiDX) 90 mg m-2 and paclitaxel (P) 175 mg m -2 with febrile neutropenia as dose-limiting toxicity. The recommended schedule for this regimen for the phase II study was EpiDX 75 mg m-2, P 175 mg m-2, etoposide (E) 100 mg m-2 intravenous (fixed dose) days 1-3 with courses repeated every 21 days. The prophylactic use of colony-stimulating factors (CSFs) was not allowed. Twenty patients entered the phase II trial: median age was 61 years (range 50-70), median Eastern Cooperative Oncology Group performance status 0 (0-2); nine patients had visceral disease and 17 had more than two metastatic sites. A total of 100 courses were administered with a median of 5 (range 1-6) per patients. Main toxicity (NCI-CTC) was myelosuppression: neutropenia grades 3 and 4 in 16 and 35% of the courses, respectively. Seven episodes of febrile neutropenia were documented and one patient required hospital admission. Nonhaematological toxicity was moderate. Seven out of 19 evaluable patients achieved a complete response (37%), nine patients (47.3%) a partial response with an overall response rate of 84.2% ((95% confidence interval = 60.4-96.6)). In this poor prognostic population of patients the triplet epirubicin/paclitaxel/ etoposide showed high antitumour activity with mild nonhaematological side effects. The use of CSFs should be able to improve the haematological profile.
| Original language | English |
|---|---|
| Pages (from-to) | 1263-1266 |
| Number of pages | 4 |
| Journal | British Journal of Cancer |
| Volume | 94 |
| Issue number | 9 |
| DOIs | |
| Publication status | Published - May 8 2006 |
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Keywords
- Epirubicin
- Etoposide
- Paclitaxel
- SCLC
ASJC Scopus subject areas
- Cancer Research
- Oncology
Cite this
Epirubicin/paclitaxel/etoposide in extensive-stage small-cell lung cancer : A phase I-II study. / Tibaldi, C.; Prochilo, T.; Russo, F.; Pennucci, M. C.; Del Freo, A.; Innocenti, F.; Fabbri, A.; Falcone, A.; Conte, P. F.; Baldini, E.
In: British Journal of Cancer, Vol. 94, No. 9, 08.05.2006, p. 1263-1266.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Epirubicin/paclitaxel/etoposide in extensive-stage small-cell lung cancer
T2 - A phase I-II study
AU - Tibaldi, C.
AU - Prochilo, T.
AU - Russo, F.
AU - Pennucci, M. C.
AU - Del Freo, A.
AU - Innocenti, F.
AU - Fabbri, A.
AU - Falcone, A.
AU - Conte, P. F.
AU - Baldini, E.
PY - 2006/5/8
Y1 - 2006/5/8
N2 - The aim of this study was to evaluate feasibility and toxicity of escalating doses of epirubicin and paclitaxel plus fixed dose of etoposide and to define the activity of the triplet in extensive disease small-cell lung cancer. Thirteen patients entered the phase I study: the maximum tolerated doses were epirubicin (EpiDX) 90 mg m-2 and paclitaxel (P) 175 mg m -2 with febrile neutropenia as dose-limiting toxicity. The recommended schedule for this regimen for the phase II study was EpiDX 75 mg m-2, P 175 mg m-2, etoposide (E) 100 mg m-2 intravenous (fixed dose) days 1-3 with courses repeated every 21 days. The prophylactic use of colony-stimulating factors (CSFs) was not allowed. Twenty patients entered the phase II trial: median age was 61 years (range 50-70), median Eastern Cooperative Oncology Group performance status 0 (0-2); nine patients had visceral disease and 17 had more than two metastatic sites. A total of 100 courses were administered with a median of 5 (range 1-6) per patients. Main toxicity (NCI-CTC) was myelosuppression: neutropenia grades 3 and 4 in 16 and 35% of the courses, respectively. Seven episodes of febrile neutropenia were documented and one patient required hospital admission. Nonhaematological toxicity was moderate. Seven out of 19 evaluable patients achieved a complete response (37%), nine patients (47.3%) a partial response with an overall response rate of 84.2% ((95% confidence interval = 60.4-96.6)). In this poor prognostic population of patients the triplet epirubicin/paclitaxel/ etoposide showed high antitumour activity with mild nonhaematological side effects. The use of CSFs should be able to improve the haematological profile.
AB - The aim of this study was to evaluate feasibility and toxicity of escalating doses of epirubicin and paclitaxel plus fixed dose of etoposide and to define the activity of the triplet in extensive disease small-cell lung cancer. Thirteen patients entered the phase I study: the maximum tolerated doses were epirubicin (EpiDX) 90 mg m-2 and paclitaxel (P) 175 mg m -2 with febrile neutropenia as dose-limiting toxicity. The recommended schedule for this regimen for the phase II study was EpiDX 75 mg m-2, P 175 mg m-2, etoposide (E) 100 mg m-2 intravenous (fixed dose) days 1-3 with courses repeated every 21 days. The prophylactic use of colony-stimulating factors (CSFs) was not allowed. Twenty patients entered the phase II trial: median age was 61 years (range 50-70), median Eastern Cooperative Oncology Group performance status 0 (0-2); nine patients had visceral disease and 17 had more than two metastatic sites. A total of 100 courses were administered with a median of 5 (range 1-6) per patients. Main toxicity (NCI-CTC) was myelosuppression: neutropenia grades 3 and 4 in 16 and 35% of the courses, respectively. Seven episodes of febrile neutropenia were documented and one patient required hospital admission. Nonhaematological toxicity was moderate. Seven out of 19 evaluable patients achieved a complete response (37%), nine patients (47.3%) a partial response with an overall response rate of 84.2% ((95% confidence interval = 60.4-96.6)). In this poor prognostic population of patients the triplet epirubicin/paclitaxel/ etoposide showed high antitumour activity with mild nonhaematological side effects. The use of CSFs should be able to improve the haematological profile.
KW - Epirubicin
KW - Etoposide
KW - Paclitaxel
KW - SCLC
UR - http://www.scopus.com/inward/record.url?scp=33646509237&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=33646509237&partnerID=8YFLogxK
U2 - 10.1038/sj.bjc.6603074
DO - 10.1038/sj.bjc.6603074
M3 - Article
C2 - 16622468
AN - SCOPUS:33646509237
VL - 94
SP - 1263
EP - 1266
JO - British Journal of Cancer
JF - British Journal of Cancer
SN - 0007-0920
IS - 9
ER -