PMID- 19460063 OWN - NLM STAT- MEDLINE DCOM- 20110118 LR - 20181201 IS - 1445-5994 (Electronic) IS - 1444-0903 (Linking) VI - 40 IP - 3 DP - 2010 Mar TI - Phase II study of paclitaxel and vinorelbine (Pacl-Vin) in hormone-refractory metastatic prostate cancer: double tubulin targeting. PG - 201-8 LID - 10.1111/j.1445-5994.2009.01987.x [doi] AB - BACKGROUND: Androgen ablation is the standard treatment for advanced prostate cancer. However, most patients will eventually develop progressive hormone-refractory prostate cancer (HRPC). The aim of the Pacl-Vin study was to determine the efficacy and safety of paclitaxel in combination with vinorelbine in patients with HRPC, following from a phase I trial. METHODS: Thirty castrate patients with progressive, metastatic prostate cancer were enrolled. Patients were treated with paclitaxel 40 mg/m2, vinorelbine 20 mg/m2 intravenously on day 1 and day 8 of a 21-day cycle. RESULTS: Two patients demonstrated a partial response and seven patients had stable disease from a cohort of 10 patients with measurable disease. Of 30 patients assessable for prostate-specific antigen (PSA) response, 19 showed stable disease, which was maintained for at least 4 weeks, while six (20%) experienced>or=50% decline in PSA levels. Median overall survival was 7.3 months (interquartile range (IQR): 4.7-9.9 months). Median progression-free survival was 3.3 months (IQR: 2.5-7.0 months). Improvement in quality of life measures was noted after three cycles of therapy. Grade 3 and 4 toxicities were: neutropenia 8%, febrile neutropenia 4%, infection 2%, anaemia 3%, lethargy 1% and somnolescence 1%. One patient died as a result of neutropenic sepsis. CONCLUSION: In a poor prognostic cohort of patients paclitaxel and vinorelbine is a tolerable regimen, with a 20% PSA and objective response rate. The majority of patients achieved PSA stability. Furthermore, quality of life parameters, such as pain, were improved. However, the low level of activity of this regimen precludes its further testing. FAU - Sewak, S AU - Sewak S AD - The Andrew Love Cancer Centre, The Geelong Hospital, Victoria, Australia. sewaks01@yahoo.com FAU - Kosmider, S AU - Kosmider S FAU - Ganju, V AU - Ganju V FAU - Woollett, A AU - Woollett A FAU - Yeow, E G AU - Yeow EG FAU - Le, B AU - Le B FAU - Henry, M AU - Henry M FAU - Debrincat, M A AU - Debrincat MA FAU - Bell, R AU - Bell R LA - eng PT - Clinical Trial, Phase II PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20090521 PL - Australia TA - Intern Med J JT - Internal medicine journal JID - 101092952 RN - 0 (Tubulin) RN - 5V9KLZ54CY (Vinblastine) RN - EC 3.4.21.77 (Prostate-Specific Antigen) RN - P88XT4IS4D (Paclitaxel) RN - Q6C979R91Y (Vinorelbine) SB - IM CIN - Intern Med J. 2010 Dec;40(12):864-5. PMID: 21199229 MH - Adenocarcinoma/drug therapy/pathology/secondary MH - Aged MH - Aged, 80 and over MH - Cohort Studies MH - Drug Administration Schedule MH - Drug Delivery Systems/*methods MH - Drug Therapy, Combination MH - Humans MH - Male MH - Middle Aged MH - Paclitaxel/*administration & dosage MH - Prostate-Specific Antigen/blood MH - Prostatic Neoplasms/blood/*drug therapy/*pathology MH - Tubulin/*blood MH - Vinblastine/administration & dosage/*analogs & derivatives MH - Vinorelbine EDAT- 2009/05/23 09:00 MHDA- 2011/01/19 06:00 CRDT- 2009/05/23 09:00 PHST- 2009/05/23 09:00 [entrez] PHST- 2009/05/23 09:00 [pubmed] PHST- 2011/01/19 06:00 [medline] AID - IMJ1987 [pii] AID - 10.1111/j.1445-5994.2009.01987.x [doi] PST - ppublish SO - Intern Med J. 2010 Mar;40(3):201-8. doi: 10.1111/j.1445-5994.2009.01987.x. Epub 2009 May 21.