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- W2000651446 abstract "CTRC-AACR San Antonio Breast Cancer Symposium: 2008 AbstractsAbstract #6116 Background: Capecitabine (C), vinorelbine (V) and docetaxel (D) are effective in the 1st line treatment of metastatic breast cancer (MBC). Based on the efficacy and the tolerability of Navcap (M. Ghosn et al. Antican Res 2006) and Navcap followed by docetaxel in MBC (M. Ghosn et al. Can Chemother Pharmacol 2008), we initiated a randomized phase II study. Primary Objective: To compare the objective response rate (ORR) of 8 cycles of Navcap vs. 4 cycles of Navcap followed by 12 weekly Docetaxel in the 1st line setting of MBC. Methods: Patients (pts) with measurable disease, no prior chemotherapy in MBC and Her-2/neu negative are eligible. All pts will receive Navcap (V 25 mg/m2 on d1 & d8 as IV push and C 825 mg/m2 bid D1-14 q3w) for 4 cycles. Pts progressing under treatment with Navcap are withdrawn and receive Docetaxel as 2nd line treatment. Pts responding or stable after completing 4 cycles of Navcap are randomized to: Arm A (4 Navcap) or Arm B (12 weekly Docetaxel 25 mg/m²/week). Results: From July 2004 to June 2008, a total of 110 pts were enrolled. At the time of this analysis 78 pts had completed the first 4 cycles of Navcap with an ORR of 55% (CR 13%) and a stable disease of 19%. 20 pts (26%) were excluded from randomization due to PD. 58 pts were randomized: Arm A: 30 pts and Arm B: 28 pts. Patient characteristics are summarized in table 1. All pts were evaluable for response with objective response rates of 70% & 78% in Arms A and B respectively. The median TTP & overall survival are 10 & 34 months in Arm A; 11 & 34 months in Arm B. Statistical comparison for efficacy & survival outcomes will be done once all pts are randomized & long term follow-up is available. All pts were evaluable for toxicity. The majority of adverse events were mild. Arm A: Gr 4 neutropenia (3%), Gr 3 anemia (6%). Arm B: Gr 3-4 anemia (9.6%), Gr 3 leukopenia (4.8%) & Gr 2 alopecia (14.3%). Conclusions: These preliminary results show that Navcap confirms its high response rate in 1st line treatment for HER-2/neu negative MBC. By the date of the meeting all pts will be randomized and will have completed their treatment. Mature data will be presented accordingly. (Protocol initiated & coordinated by the Cancer Research Group/Collaborative Group, Beirut–Lebanon). ![][1] Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 6116. [1]: /embed/graphic-1.gif" @default.
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- W2000651446 date "2009-01-15" @default.
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- W2000651446 title "Randomized multicenter phase II trial of navcap (vinorelbine and capecitabine) versus navcap followed by weekly docetaxel as first line treatment in HER-2/neu negative metastatic breast cancer patients: updated results." @default.
- W2000651446 doi "https://doi.org/10.1158/0008-5472.sabcs-6116" @default.
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!["CTRC-AACR San Antonio Breast Cancer Symposium: 2008 AbstractsAbstract #6116 Background: Capecitabine (C), vinorelbine (V) and docetaxel (D) are effective in the 1st line treatment of metastatic breast cancer (MBC). Based on the efficacy and the tolerability of Navcap (M. Ghosn et al. Antican Res 2006) and Navcap followed by docetaxel in MBC (M. Ghosn et al. Can Chemother Pharmacol 2008), we initiated a randomized phase II study. Primary Objective: To compare the objective response rate (ORR) of 8 cycles of Navcap vs. 4 cycles of Navcap followed by 12 weekly Docetaxel in the 1st line setting of MBC. Methods: Patients (pts) with measurable disease, no prior chemotherapy in MBC and Her-2/neu negative are eligible. All pts will receive Navcap (V 25 mg/m2 on d1 & d8 as IV push and C 825 mg/m2 bid D1-14 q3w) for 4 cycles. Pts progressing under treatment with Navcap are withdrawn and receive Docetaxel as 2nd line treatment. Pts responding or stable after completing 4 cycles of Navcap are randomized to: Arm A (4 Navcap) or Arm B (12 weekly Docetaxel 25 mg/m²/week). Results: From July 2004 to June 2008, a total of 110 pts were enrolled. At the time of this analysis 78 pts had completed the first 4 cycles of Navcap with an ORR of 55% (CR 13%) and a stable disease of 19%. 20 pts (26%) were excluded from randomization due to PD. 58 pts were randomized: Arm A: 30 pts and Arm B: 28 pts. Patient characteristics are summarized in table 1. All pts were evaluable for response with objective response rates of 70% & 78% in Arms A and B respectively. The median TTP & overall survival are 10 & 34 months in Arm A; 11 & 34 months in Arm B. Statistical comparison for efficacy & survival outcomes will be done once all pts are randomized & long term follow-up is available. All pts were evaluable for toxicity. The majority of adverse events were mild. Arm A: Gr 4 neutropenia (3%), Gr 3 anemia (6%). Arm B: Gr 3-4 anemia (9.6%), Gr 3 leukopenia (4.8%) & Gr 2 alopecia (14.3%). Conclusions: These preliminary results show that Navcap confirms its high response rate in 1st line treatment for HER-2/neu negative MBC. By the date of the meeting all pts will be randomized and will have completed their treatment. Mature data will be presented accordingly. (Protocol initiated & coordinated by the Cancer Research Group/Collaborative Group, Beirut–Lebanon). ![][1] Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 6116. [1]: /embed/graphic-1.gif"](?object=%22CTRC-AACR%20San%20Antonio%20Breast%20Cancer%20Symposium%3A%202008%20AbstractsAbstract%20%236116%20Background%3A%20Capecitabine%20(C)%2C%20vinorelbine%20(V)%20and%20docetaxel%20(D)%20are%20effective%20in%20the%201st%20line%20treatment%20of%20metastatic%20breast%20cancer%20(MBC).%20Based%20on%20the%20efficacy%20and%20the%20tolerability%20of%20Navcap%20(M.%20Ghosn%20et%20al.%20Antican%20Res%202006)%20and%20Navcap%20followed%20by%20docetaxel%20in%20MBC%20(M.%20Ghosn%20et%20al.%20Can%20Chemother%20Pharmacol%202008)%2C%20we%20initiated%20a%20randomized%20phase%20II%20study.%20Primary%20Objective%3A%20To%20compare%20the%20objective%20response%20rate%20(ORR)%20of%208%20cycles%20of%20Navcap%20vs.%204%20cycles%20of%20Navcap%20followed%20by%2012%20weekly%20Docetaxel%20in%20the%201st%20line%20setting%20of%20MBC.%20Methods%3A%20Patients%20(pts)%20with%20measurable%20disease%2C%20no%20prior%20chemotherapy%20in%20MBC%20and%20Her-2%2Fneu%20negative%20are%20eligible.%20All%20pts%20will%20receive%20Navcap%20(V%2025%20mg%2Fm2%20on%20d1%20%26%20d8%20as%20IV%20push%20and%20C%20825%20mg%2Fm2%20bid%20D1-14%20q3w)%20for%204%20cycles.%20Pts%20progressing%20under%20treatment%20with%20Navcap%20are%20withdrawn%20and%20receive%20Docetaxel%20as%202nd%20line%20treatment.%20Pts%20responding%20or%20stable%20after%20completing%204%20cycles%20of%20Navcap%20are%20randomized%20to%3A%20Arm%20A%20(4%20Navcap)%20or%20Arm%20B%20(12%20weekly%20Docetaxel%2025%20mg%2Fm%C2%B2%2Fweek).%20Results%3A%20From%20July%202004%20to%20June%202008%2C%20a%20total%20of%20110%20pts%20were%20enrolled.%20At%20the%20time%20of%20this%20analysis%2078%20pts%20had%20completed%20the%20first%204%20cycles%20of%20Navcap%20with%20an%20ORR%20of%2055%25%20(CR%2013%25)%20and%20a%20stable%20disease%20of%2019%25.%2020%20pts%20(26%25)%20were%20excluded%20from%20randomization%20due%20to%20PD.%2058%20pts%20were%20randomized%3A%20Arm%20A%3A%2030%20pts%20and%20Arm%20B%3A%2028%20pts.%20Patient%20characteristics%20are%20summarized%20in%20table%201.%20All%20pts%20were%20evaluable%20for%20response%20with%20objective%20response%20rates%20of%2070%25%20%26%2078%25%20in%20Arms%20A%20and%20B%20respectively.%20The%20median%20TTP%20%26%20overall%20survival%20are%2010%20%26%2034%20months%20in%20Arm%20A%3B%2011%20%26%2034%20months%20in%20Arm%20B.%20Statistical%20comparison%20for%20efficacy%20%26%20survival%20outcomes%20will%20be%20done%20once%20all%20pts%20are%20randomized%20%26%20long%20term%20follow-up%20is%20available.%20All%20pts%20were%20evaluable%20for%20toxicity.%20The%20majority%20of%20adverse%20events%20were%20mild.%20Arm%20A%3A%20Gr%204%20neutropenia%20(3%25)%2C%20Gr%203%20anemia%20(6%25).%20Arm%20B%3A%20Gr%203-4%20anemia%20(9.6%25)%2C%20Gr%203%20leukopenia%20(4.8%25)%20%26%20Gr%202%20alopecia%20(14.3%25).%20Conclusions%3A%20These%20preliminary%20results%20show%20that%20Navcap%20confirms%20its%20high%20response%20rate%20in%201st%20line%20treatment%20for%20HER-2%2Fneu%20negative%20MBC.%20By%20the%20date%20of%20the%20meeting%20all%20pts%20will%20be%20randomized%20and%20will%20have%20completed%20their%20treatment.%20Mature%20data%20will%20be%20presented%20accordingly.%20(Protocol%20initiated%20%26%20coordinated%20by%20the%20Cancer%20Research%20Group%2FCollaborative%20Group%2C%20Beirut%E2%80%93Lebanon).%20!%5B%5D%5B1%5D%20Citation%20Information%3A%20Cancer%20Res%202009%3B69(2%20Suppl)%3AAbstract%20nr%206116.%20%5B1%5D%3A%20%2Fembed%2Fgraphic-1.gif%22){kind=link}