A Real-World Retrospective Cohort Study of Combined Therapy with Bevacizumab and Paclitaxel in Japanese Patients with Metastatic Breast Cancer

Yamada, Hirofumi; Inoue, Kentaro; Nagai, Shigenori; Nakai, Masami; Arisawa, Fumio; Ueda, Hiroyuki; Saito, Tsuyoshi; Ninomiya, Jun; Kuroda, Tôru; Sakurai, Takashi; Kodama, Hitoshi; Kimizuka, Kei; Hata, Satoshi; Kai, Toshihiro; Kurosumi, Masafumi; investigators, Sbccsg

doi:10.1272/jnms.84.215

Cited by 1 publication

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“…An open-label phase II study of bevacizumab in combination with weekly paclitaxel in Japanese patients with MBC [ 19 ] suggested that the activity and tolerability of the combination therapy as first-line therapy were reproducible in the Japanese patient population; again, the incidence of peripheral neuropathy was high. Our previous cohort study [ 20 ] also verified both the high efficacy and safety of the PB regimen but disclosed a high dose reduction rate of 28% in patients who had received the initial paclitaxel dose of 90 mg/m 2 . Hence, a need to develop a chemotherapeutic regimen that is less likely to cause dose reductions in paclitaxel emerged.…”

Section: Introductionmentioning

confidence: 69%

“…In our prior clinical study [ 20 ], median TTF for the PB regimen was 6.2 months (95% CI: 4.2–8.3). Therefore, we established an expected TTF of 9.0 months and a threshold TTF of 6.2 months in patients with MBC whose response to treatment is SD or better after 3 cycles (2.8 months) of the PB regimen.…”

Section: Methodsmentioning

confidence: 99%

“…The reported incidences of peripheral neuropathy have been higher for taxane-based therapy [ 17 , 21 , 22 ] than for eribulin monotherapy [ 12 – 16 ]. The rational of switching from the former to the latter emerged in expectation of the potential reduction in peripheral neuropathy by eribulin [ 16 , 20 ].…”

Section: Introductionmentioning

confidence: 99%

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Induction therapy with paclitaxel and bevacizumab followed by switch maintenance therapy with eribulin in Japanese patients with HER2-negative metastatic breast cancer: a multicenter, collaborative, open-label, phase II clinical study for the SBCCSG 35 investigators

Inoue¹,

Ninomiya²,

Saito³

et al. 2018

BMC Cancer

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BackgroundTo examine the efficacy and safety of induction therapy with paclitaxel and bevacizumab followed by switch maintenance therapy with eribulin (ISMT) in Japanese patients with HER2-negative metastatic breast cancer (MBC).MethodsPatients, who had previously undergone a maximum of 2 regimens of chemotherapy, received 3 cycles of induction therapy with paclitaxel (90 mg/m2 intravenously on days 1, 8, and 15 followed by 1-week drug holiday) and bevacizumab (10 mg/kg intravenously after the completion of paclitaxel administration on days 1 and 15). Patients who had complete response, partial response, or stable disease underwent switch maintenance therapy with eribulin (1.4 mg/m2 intravenously on days 1 and 8 followed by 1-week drug holiday). The primary endpoint was time to treatment failure (TTF) for ISMT.ResultsFifty-one eligible patients (median age: 66 years; range: 35–74) were enrolled: 19 (37.3%) and 32 (62.7%) had stage IV and recurrence, respectively, 42 (82.4%) had visceral metastases, and 45 (88.2%) received eribulin—38 of whom showed disease progression, and 40 (78.4%) underwent post therapy. Median TTF was 9.2 months (95% confidence interval [CI]: 7.3–11.1), median progression-free survival was 10.7 months (95% CI: 9.6–11.8), and median overall survival was 20.0 months (95% CI: 16.0–24.0). Relative dose intensity was 97.7% (range: 33.3–100.0) for induction therapy and was 83.3% (range: 49.3–100.6%) for eribulin maintenance therapy. The most common adverse event was alopecia (51 [100%]) in induction therapy and was peripheral sensory neuropathy (37 [82.2%]) in eribulin maintenance therapy. Eribulin was effective with manageable tolerability.ConclusionsISMT may be a promising therapeutic option for patients with MBC.Trial registrationUMIN000015971. Registration date: January 1, 2015.

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Section: Introductionmentioning

confidence: 69%

Section: Methodsmentioning

confidence: 99%