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ASCO 2000, abstract 424

Epirubicin + Docetaxel (ET) in Advanced Breast Cancer: Preliminary Results.

Epirubicin 75 mg/m2 iv + Taxotere 75 mg/m2 iv on day 1, Q3 wks up to 6 cycles.
Premedication includes dexamethasone & antiemetics. Previous therapy for ABC was not allowed.N=43 patients. Main hematologic toxicity : neutropenic fever in 7% of the cycles. Non hematologic toxicity, per cycle, all grades were: alopecia (as the main side effect) 83%, asthenia 21% (G3-4 1%), stomatitis 24% (G3-4 2%), vomiting 12% (G3-4 1%), neuromotor 10% (G3-4 2%). Compliance was the expected, with only 11% delayed cycles and dose reduction 3%.
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TAXOL QW
Taxol 90 mg/m2 IV
Repeat Q week
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TAXOL Q3W
175-225 mg/m2 over 3 hrs
RR 21-42% JCO 14: 1858,1996

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TAXOTERE QW
40 mg/m2 qweek
JCO 18(6): 1212 , 2000

TAXOTERE QW (elderly)
DOCETAXEL 36 mg/m2 infused IV over 1 hour QWEEK X 6 weeks followed by two weeks of rest. Re-evaluate at 8 weeks.

Prophylaxis: Dexamethasone 8 mg po 12 hours before docetaxel administration, at the time of docetaxel sdministration, & 12 hours after treatment.
Check CBC: WBC to be > 1500/uL, PLT<75,000/uL.
If grade 3-4 non-heme toxicity, restart at 75% dose after resolution of taxicity to grade 2 or less.

Ref: JCO 19:3500, 2001. N=41; 5% had grade 3/4 leukopenia. The only common toxicity was treatment-related fatigue (cumulative). RR~40%.

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TAXOTERE Q3W
Taxotere 100 mg IV over 1 hours
Repeat Q21 days
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TAXOTERE + HERPCEPTIN
REF: Semin Oncol 2001 Feb;28(1 Suppl 3):38-44

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NAVALBINE
Navalbine 25 mg/m2 Qweek

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NAVALBINE & HERCEPTIN
Herceptin 4 mg/kg loading dose followed by 2 mg/kg Qweek
Navalbine 25 mg/mz Qweek

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CAPECITABINE
Capecitabine 1250 mg/m2 Bid X 14 days followed by 1 week rest.
If clinically sig. hand-foot synd. then stop Capecitabine & restart lower dose.

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TAXOTERE & CAPECITABINE
Taxotere 75 mg/m2 Day1
Capecitabine 1250 mg/m2 Bid X 14 days

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HERCEPTIN
Herceptin 4 mg/kg loading dose followed by 2 mg/kg Qweek

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EPIRUBICIN (single agent)
70 mg/m2 days 1 & 8 q4 weeks

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HERCEPTIN+TAXOL+CARBOPLATIN
Herceptin 8 mg/kg loading then 4 mq/kg qweek x 6 of 8 wks
Taxol 70 mg/m2 qweek x 6 of 8 wks
Carbo. AUC=2 qweek x 6 of 8 wks
Ref=Abstract BCS Burris et al.

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TAXOL+CARBOPLATIN (weekly)
Taxol 100 mg/m2 over 1 hour qweek x 6 of 8 wks
Carbo. AUC=2 IV over 30-60 min qweek x 6 of 8 wks
Ref=Abstract BCS Loesh, D et al.

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TAXOL+CARBOPLATIN (q3week)
Taxol 200 mg/m2 over 3 hours q3 weeks
Carbo. AUC=6 IV q3 weeks
REF=Cancer 88: 124-131, 2000. 12 month survival 72%.

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ADRIAMYCIN Qweek

Doxorubicin 20 mg/m2 day 1
Repeat Qweek
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Interesting Abstracts:

Superior Survival With Capecitabine Plus Docetaxel Combination Therapy in Anthracycline-Pretreated Patients With Advanced Breast Cancer: Phase III Trial Results

Docetaxel and capecitabine, a tumor-activated oral fluoropyrimidine, show high single-agent efficacy in metastatic breast cancer (MBC) and synergy in preclinical studies. This international phase III trial compared efficacy and tolerability of capecitabine/docetaxel therapy with single-agent docetaxel in anthracycline-pretreated patients with MBC.

PATIENTS AND METHODS: Patients were randomized to 21-day cycles of oral capecitabine 1,250 mg/m2 twice daily on days 1 to 14 plus docetaxel 75 mg/m2 on day 1 (n = 255) or to docetaxel 100 mg/m2 on day 1 (n = 256).

RESULTS: Capecitabine/docetaxel resulted in significantly superior efficacy in time to disease progression (TTP) (hazard ratio, 0.652; 95% confidence interval [CI], 0.545 to 0.780; P = .0001; median, 6.1 v 4.2 months), overall survival (hazard ratio, 0.775; 95% CI, 0.634 to 0.947; P = .0126; median, 14.5 v 11.5 months), and objective tumor response rate (42% v 30%, P = .006) compared with docetaxel. Gastrointestinal side effects and hand-foot syndrome were more common with combination therapy, whereas myalgia, arthralgia, and neutropenic fever/sepsis were more common with single-agent docetaxel. More grade 3 adverse events occurred with combination therapy (71% v 49%, respectively), whereas grade 4 events were slightly more common with docetaxel (31% v 25% with combination).

CONCLUSION: The significantly superior TTP and survival achieved with the addition of capecitabine to docetaxel 75 mg/m2, with the manageable toxicity profile, indicate that this combination provides clear benefits over single-agent docetaxel 100 mg/m2. Docetaxel/capecitabine therapy is an important treatment option for women with anthracycline-pretreated MBC.

Xeloda (capecitabine) + docetaxel combination therapy in locally advanced/metastatic breast cancer: latest results.







Vukelja SJ, et al. San Antonio 2001



511 patients with anthracycline-pretreated locally advanced/metastatic breast cancer were randomized to 21-day cycles of either combination therapy (X 1250mg/m2 bid, d1-14 plus D 75mg/m2, d1; n=255) or monotherapy (D 100mg/m2, d1; n=256). The primary efficacy endpoint is TTP. In the first report of this trial [O'Shaughnessy et al SABCS 2000:A381] overall survival was significantly superior with X+D, with median survival of 13.7 vs 11.1 months, respectively. We report here the latest results. Results: Minimum follow-up is now 15 months. X+D resulted in significantly superior OS (HR=0.775 [95% CI: 0.63-0.95], p=0.0126, median 14.5 vs 11.5m with monotherapy), TTP (HR=0.652 [95% CI: 0.54-0.77], p=0.0001, median 6.1 vs 4.2m), and RR (42 vs 30%, p=0.006). Treatment-related adverse events (AE) occurred in 98% and 94% of the X+D and D arms, respectively. Patients receiving X+D experienced a higher incidence of gastrointestinal AE and hand-foot syndrome, whereas there was more neutropenic fever, arthralgia and pyrexia in the monotherapy group. Grade 4 AE were less common with X+D (25% vs 30%, due to neutropenic fever in the D arm). Grade 3 AE were more common in the X+D arm, primarily owing to hand-foot syndrome in the second cycle. X+D AE were effectively managed with appropriate medical intervention, treatment interruption and if necessary, dose reduction. Conclusions: X+D therapy offers the unique benefit of superior OS, with a manageable safety profile. It is a highly effective new combination chemotherapy for the treatment of advanced disease.

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JCO 20(11): 2689, 2002

1st line metastatic disease



EPIRUBICIN + NAVALBINE



EPI 100 mg/m2 IV bolus day 1

Vinorelbine 25 mg/m2 IV over 30 minutes on days 1 & 5

Q 3 weeks for up to 8 cycles.

All patients also received G- CSF days 7 - 12



RESULTS: OR at least 4 weeks after the first documentation, were observed in 65 of 92 assessable pts (70.6%; 95% CI, 62% to 80%). Stable disease in 17 pts (18.5%). Responses were observed in all disease sites, being 94% in soft tissue, 60% in bone, & 66% in visceral disease. Median time to response, median duration of response, median time to progression, & median overall survival were 2, 9, 10, & 26 months, respectively. The dose-limiting toxicity was neutropenia, which was grade 4 in 36% of the patients, & was accompanied by fever in 26% of the cases. Grade 3 - 4 mucositis: 28%. Other toxicities were mild - moderate. No cardiotoxicity was observed.