Adjuvant Capecitabine for Breast Cancer after Preoperative Chemotherapy

Masuda, Norikazu; Lee, Soo-Jung; Ohtani, Shoichiro; Im, Young‐Hyuck; Lee, Eun-Sook; Yokota, Isao; Kuroi, Katsumasa; Im, Seock‐Ah; Park, Byeong Woo; Kim, Sung‐Bae; Yanagita, Yasuhiro; Ohno, Shinji; Takao, Shintaro; Aogi, Kenjiro; Iwata, Hiroji; Lee, Jeong Eon; Kim, Aeree; Park, Kyong-Hwa; Sasano, Hironobu; Ohashi, Yasuo; Toi, Masakazu

doi:10.1056/nejmoa1612645

Cited by 1,305 publications

(893 citation statements)

References 31 publications

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“…Taken together, these data may suggest that if a tumor belongs to the group with no apparent response to NAC, no apparent change or an increased in the Ki67 level may be an indicator of unfavorable prognosis. The selection of patients with residual disease at high risk after NAC is crucial to tailoring a more accurate individualized therapy, such as the administration of an LHRH analogue for premenopausal HR(+) patients, extension of targeted therapy for Her-2(+) patients, and administration of Capecitabine, which significantly increased OS in Her-2(–) patients with residual disease 35 . …”

Section: Discussionmentioning

confidence: 99%

Decrease in the Ki67 index during neoadjuvant chemotherapy predicts favorable relapse-free survival in patients with locally advanced breast cancer

Chen

Zhang²,

Huang

et al. 2019

Cancer Biol Med

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Objective: The purpose of this study was to explore the optimal cutoffs of the three parameters of Ki67 during NAC for predicting patient prognosis and investigate whether the optimal cutoffs of the Ki67 values were associated with relapse-free survival (RFS) or breast cancer-specific survival (BCSS). Methods: A total of 92 patients with locally advanced breast cancer (LABC), who had residual disease after NAC were retrospectively investigated. The optimal cutoff values of the Ki67 parameters were assessed by the online algorithm Cutoff Finder. Kaplan-Meier analysis, the log-rank test and Cox regression analysis were carried out to analyze survival. Results: The optimal cutoff values for the postsurgical Ki67 level and the decrease in the Ki67 level during NAC were defined as 25% and 12.5%, respectively. According to the univariate survival analysis, a higher Ki67 level in residual disease was associated with poor RFS (P = 0.004) and BCSS (P = 0.014). In addition, a Ki67 expression decrease > 12.5% during NAC was related to favorable RFS ( P = 0.007), but was not related to BCSS (P = 0.452). Cox regression analysis showed that the Ki67 expression decrease (> 12.5% vs. = 12.5%) and histological grade (grade 3 vs. grade 1-2) were the independent factors associated with RFS (P = 0.020 and P = 0.023, respectively), with HR values of 0.353 (95% CI: 0.147-0.850) and 3.422 (95% CI: 1.188-9.858), respectively. Conclusions: The Ki67 decrease was one of the independent factors associated with RFS in LABC patients with residual disease after receiving NAC.

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Section: Discussionmentioning

confidence: 99%

Decrease in the Ki67 index during neoadjuvant chemotherapy predicts favorable relapse-free survival in patients with locally advanced breast cancer

Chen

Zhang²,

Huang

et al. 2019

Cancer Biol Med

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“…In contrast, another study found that standard adjuvant chemotherapy (classical CMF or doxorubicin/cyclophosphamide (AC)) was superior to capecitabine in older patients, and the benefit was pronounced in those with hormone receptor-negative breast cancer [20]. Recently, it was reported that adjuvant capecitabine (1,250 mg/m 2 tid weeks 1 and 2 of a 3-week cycle for 6 or 8 cycles) improved outcome in breast cancer patients who did not achieve pathologic complete response after neoadjuvant chemotherapy [21]. In the subgroup of patients with TN disease, the DFS rate was 69% in the capecitabine group compared with 56% in the control group [21].…”

Section: Discussionmentioning

confidence: 99%

“…Recently, it was reported that adjuvant capecitabine (1,250 mg/m 2 tid weeks 1 and 2 of a 3-week cycle for 6 or 8 cycles) improved outcome in breast cancer patients who did not achieve pathologic complete response after neoadjuvant chemotherapy [21]. In the subgroup of patients with TN disease, the DFS rate was 69% in the capecitabine group compared with 56% in the control group [21]. This suggests that capecitabine should be further investigated in TN breast cancer.…”

Section: Discussionmentioning

confidence: 99%

Metronomic Chemotherapy for First-Line Treatment of Metastatic Triple-Negative Breast Cancer: A Phase II Trial

et al. 2018

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Background: Few data are available on the benefit of metronomic cyclophosphamide, capecitabine, and vinorelbine as first-line therapy in patients with metastatic triple-negative breast cancer. Methods: This phase II study assessed the safety and efficacy of metronomic oral chemotherapy with vinorelbine 40 mg orally 3 times a week, cyclophosphamide 50 mg daily, and capecitabine 500 mg 3 times a day (VEX regimen) in untreated metastatic triple-negative breast cancer patients. The biopsy of the metastatic site had to be triple-negative, independent of the hormone receptor expression of the primary tumor. The primary endpoint was time to progression (TTP). Secondary endpoints included assessment of safety and clinical benefit (objective response rate plus stable disease rate at ≥24 weeks). Results: 25 patients were included, and 22 were evaluable for both efficacy and toxicities (median age, 66 years). Median TTP was 6.4 months (95% confidence interval 3.6-12.6). The most common grade 1-2 toxicities were nausea, diarrhea, leuko-/neutropenia, and reversible liver enzyme alteration. Grade 3 events included hand and foot syndrome (9%). Conclusion: The VEX regimen demonstrated activity and was relatively well tolerated when given as first-line therapy in selected metastatic breast cancer patients with triple-negative disease.

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“…It is of interest that some neoadjuvant breast cancer trials demonstrated an advantage of switching to another drug cocktail in patients with noncomplete pathologic response. 31,32 We are currently trying to address the previously mentioned issues in the new NACT trial involving OC patients with BRCA1 germ-line mutations. To intensify primary therapy, we have added doxorubicin (30 mg/m 2 , given on days 1 and 8) to the cisplatin (80 mg/m 2 ) and mitomycin C (10 mg/m 2 ) combination.…”

Section: Discussionmentioning

confidence: 99%

Atl

Gorodnova

Kotiv

Ivantsov

et al. 2018

Int J Gynecol Cancer

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ObjectivesCisplatin and mitomycin C exert high activity towards BRCA1-deficient cells. This study aimed to evaluate the efficacy of a combination of these drugs in hereditary BRCA1-associated ovarian cancer (OC).MethodsTwelve OC patients, who could not be treated by primary debulking surgery owing to extensive tumor spread, were given neoadjuvant cisplatin (100 mg/m2) and mitomycin C (10 mg/m2) every 4 weeks for 3 (n = 9), 2 (n = 2), or 4 (n = 1) cycles.ResultsThe decrease of tumor burden and complete surgical cytoreduction were achieved in all patients. Pathologic complete response, defined as the absence of tumor cells in surgically removed tissues, was observed in 2 (17%) of 12 cases. Retrospective analysis of 62 OC in BRCA1 mutation carriers subjected to conventional neoadjuvant chemotherapy schemes revealed 36 objective tumor responses (58%) and 37 instances (60%) of complete cytoreductive surgery; however, none of these patients demonstrated pathologic complete response.ConclusionsThe combination of cisplatin plus mitomycin C showed promising results in BRCA1-driven OC and therefore deserves further clinical evaluation.

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Adjuvant Capecitabine for Breast Cancer after Preoperative Chemotherapy

Cited by 1,305 publications

References 31 publications

Decrease in the Ki67 index during neoadjuvant chemotherapy predicts favorable relapse-free survival in patients with locally advanced breast cancer

Decrease in the Ki67 index during neoadjuvant chemotherapy predicts favorable relapse-free survival in patients with locally advanced breast cancer

Metronomic Chemotherapy for First-Line Treatment of Metastatic Triple-Negative Breast Cancer: A Phase II Trial

Atl

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