Abstract
Background: The aim of this study was to determine the maximum tolerated dose (MTD) of liposomal doxorubicin (LD)-vinorelbine (V) in patients with refractory or resistant ovarian cancer. Patients and methods: Thirty patients were eligible. Seven levels were studied [LD 25-V20 (three patients enrolled); LD 30-V20 (three); LD 35-V20 (three); LD 20-V25 (three); LD 25-V25 (three); LD 30-V25 (10); LD 35-V25 (five)]. LD was given on day 1, while V was given on days 1 and 8 every 21 days. Cohorts of three patients were enrolled at each level, and another three patients were planned, if one dose-limiting toxicity (DLT) was registered. Results: DLT was observed in four patients: two febrile neutropenia, one grade 4 thrombocytopenia and one grade 3 palmar-plantar erythrodysesthesia (PPE) at level 7 (LD 35-V25). Thus, liposomal doxorubicin 30 mg/m2 plus vinorelbine 25 mg/m2 was the MTD. The most frequent toxicity was neutropenia. Fifteen patients (50%) experienced grade 3 neutropenia and 10 (33.3%) grade 4 neutropenia. Non-hematological toxicity was mild. Mucositis and PPE were the most frequent toxicities, but in most cases were grade 1. Out of 29 assessable patients, six (20.7%; 95% confidence interval 10%-39%) experienced an objective response, with one complete response. Conclusions: In patients with refractory or resistant ovarian cancer, the recommended doses for the combination studied are liposomal doxorubicin 30 mg/m2 (day 1) plus vinorelbine 25 mg/m2 (day 1 and 8). Neutropenia is the most frequent toxicity, while non-hematological toxicity is mild. Substantial activity was recorded and a phase II study is justified.
| Original language | English |
|---|---|
| Pages (from-to) | 1406-1411 |
| Number of pages | 6 |
| Journal | Annals of Oncology |
| Volume | 14 |
| Issue number | 9 |
| DOIs | |
| Publication status | Published - Sep 1 2003 |
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Keywords
- Liposomal doxorubicin
- Ovarian cancer
- Phase I
- Vinorelbine
ASJC Scopus subject areas
- Oncology
- Cancer Research
Cite this
An escalating dose finding study of liposomal doxorubicin and vinorelbine for the treatment of refractory or resistant epithelial ovarian cancer. / Tambaro, R.; Greggi, S.; Iaffaioli, R. V.; Rossi, A.; Pisano, C.; Manzione, L.; Ferrari, E.; Di Maio, M.; Iodice, F.; Casella, G.; Laurelli, G.; Pignata, S.
In: Annals of Oncology, Vol. 14, No. 9, 01.09.2003, p. 1406-1411.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - An escalating dose finding study of liposomal doxorubicin and vinorelbine for the treatment of refractory or resistant epithelial ovarian cancer
AU - Tambaro, R.
AU - Greggi, S.
AU - Iaffaioli, R. V.
AU - Rossi, A.
AU - Pisano, C.
AU - Manzione, L.
AU - Ferrari, E.
AU - Di Maio, M.
AU - Iodice, F.
AU - Casella, G.
AU - Laurelli, G.
AU - Pignata, S.
PY - 2003/9/1
Y1 - 2003/9/1
N2 - Background: The aim of this study was to determine the maximum tolerated dose (MTD) of liposomal doxorubicin (LD)-vinorelbine (V) in patients with refractory or resistant ovarian cancer. Patients and methods: Thirty patients were eligible. Seven levels were studied [LD 25-V20 (three patients enrolled); LD 30-V20 (three); LD 35-V20 (three); LD 20-V25 (three); LD 25-V25 (three); LD 30-V25 (10); LD 35-V25 (five)]. LD was given on day 1, while V was given on days 1 and 8 every 21 days. Cohorts of three patients were enrolled at each level, and another three patients were planned, if one dose-limiting toxicity (DLT) was registered. Results: DLT was observed in four patients: two febrile neutropenia, one grade 4 thrombocytopenia and one grade 3 palmar-plantar erythrodysesthesia (PPE) at level 7 (LD 35-V25). Thus, liposomal doxorubicin 30 mg/m2 plus vinorelbine 25 mg/m2 was the MTD. The most frequent toxicity was neutropenia. Fifteen patients (50%) experienced grade 3 neutropenia and 10 (33.3%) grade 4 neutropenia. Non-hematological toxicity was mild. Mucositis and PPE were the most frequent toxicities, but in most cases were grade 1. Out of 29 assessable patients, six (20.7%; 95% confidence interval 10%-39%) experienced an objective response, with one complete response. Conclusions: In patients with refractory or resistant ovarian cancer, the recommended doses for the combination studied are liposomal doxorubicin 30 mg/m2 (day 1) plus vinorelbine 25 mg/m2 (day 1 and 8). Neutropenia is the most frequent toxicity, while non-hematological toxicity is mild. Substantial activity was recorded and a phase II study is justified.
AB - Background: The aim of this study was to determine the maximum tolerated dose (MTD) of liposomal doxorubicin (LD)-vinorelbine (V) in patients with refractory or resistant ovarian cancer. Patients and methods: Thirty patients were eligible. Seven levels were studied [LD 25-V20 (three patients enrolled); LD 30-V20 (three); LD 35-V20 (three); LD 20-V25 (three); LD 25-V25 (three); LD 30-V25 (10); LD 35-V25 (five)]. LD was given on day 1, while V was given on days 1 and 8 every 21 days. Cohorts of three patients were enrolled at each level, and another three patients were planned, if one dose-limiting toxicity (DLT) was registered. Results: DLT was observed in four patients: two febrile neutropenia, one grade 4 thrombocytopenia and one grade 3 palmar-plantar erythrodysesthesia (PPE) at level 7 (LD 35-V25). Thus, liposomal doxorubicin 30 mg/m2 plus vinorelbine 25 mg/m2 was the MTD. The most frequent toxicity was neutropenia. Fifteen patients (50%) experienced grade 3 neutropenia and 10 (33.3%) grade 4 neutropenia. Non-hematological toxicity was mild. Mucositis and PPE were the most frequent toxicities, but in most cases were grade 1. Out of 29 assessable patients, six (20.7%; 95% confidence interval 10%-39%) experienced an objective response, with one complete response. Conclusions: In patients with refractory or resistant ovarian cancer, the recommended doses for the combination studied are liposomal doxorubicin 30 mg/m2 (day 1) plus vinorelbine 25 mg/m2 (day 1 and 8). Neutropenia is the most frequent toxicity, while non-hematological toxicity is mild. Substantial activity was recorded and a phase II study is justified.
KW - Liposomal doxorubicin
KW - Ovarian cancer
KW - Phase I
KW - Vinorelbine
UR - http://www.scopus.com/inward/record.url?scp=17144438486&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=17144438486&partnerID=8YFLogxK
U2 - 10.1093/annonc/mdg364
DO - 10.1093/annonc/mdg364
M3 - Article
C2 - 12954580
AN - SCOPUS:17144438486
VL - 14
SP - 1406
EP - 1411
JO - Annals of Oncology
JF - Annals of Oncology
SN - 0923-7534
IS - 9
ER -