The Trastuzumab and Vinorelbine Combination: An Alternative to Taxane-Based Chemotherapy for Early-Stage and Locally Advanced HER2-Positive Breast Cancer

Esfahani, Khashayar; Ferrario, Cristiano; Le, Philippe; Panasci, Lawrence

doi:10.3747/co.21.2069

Cited by 9 publications

(6 citation statements)

References 14 publications

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“…In this retrospective study, we found that TV in the adjuvant setting had encouraging efficacy, but a milder toxicity profile (no long-term neuropathy or alopecia). Our results are consistent with other studies supporting a favorable toxicity profile and clinical activity of the TV regimen in treatment of metastatic 11,12 and early-stage 14,15 HER2+ BC. Our work supports the findings from important earlier works that evaluated the TV regimen in early HER2-positive BC 14,15 with the advantage of longer follow-up, and data from a more recent follow-up period, reflecting contemporary clinical guidelines for that patient population.…”

Section: Discussionsupporting

confidence: 93%

“…Our results are consistent with other studies supporting a favorable toxicity profile and clinical activity of the TV regimen in treatment of metastatic 11,12 and early-stage 14,15 HER2+ BC. Our work supports the findings from important earlier works that evaluated the TV regimen in early HER2-positive BC 14,15 with the advantage of longer follow-up, and data from a more recent follow-up period, reflecting contemporary clinical guidelines for that patient population. In addition, our work included a more uniform cohort of low-risk early HER2+ patients who received the TV regimen in the adjuvant treatment instead of the accepted TH regimen, unlike other studies which included patients in the neoadjuvant setting that were likely higher-risk patients who would have received a more aggressive regimen according to current guidelines, if treated today.…”

Section: Discussionsupporting

confidence: 93%

“…10,13 In addition, the TV regimen was evaluated in two retrospective studies in the adjuvant and neoadjuvant setting of early HER2+ BC. 14,15 However, since the time of these publications, clinical guidelines have evolved to increasingly recommend neoadjuvant therapy for many patients with localized HER2+ BC and therefore several of the patients included in the prior studies of the TV regimen would now have received neoadjuvant therapy. Therefore, there is a need to examine contemporary outcomes for patients with low-risk HER2-positive tumors for whom neoadjuvant therapy would not be offered and evaluate whether TV provides a suitable alternative to TH in select patients.…”

Section: Introductionmentioning

confidence: 99%

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Adjuvant trastuzumab and vinorelbine for early-stage HER2+ breast cancer

et al. 2023

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Background: The single-arm phase II APT trial established trastuzumab and paclitaxel (TH) as the standard adjuvant regimen for small human epidermal growth factor receptor 2 (HER2+) tumors. However, paclitaxel causes alopecia and has high rates of neuropathy and hypersensitivity reactions. In patients with metastatic HER2+ breast cancer (BC), the combination of trastuzumab and vinorelbine (TV) is effective and well tolerated. There is a need for alternative non-anthracycline/taxane-based regimens for patients with HER2+ early-stage BC, especially for those with contraindications or who wish to avoid side effects of taxane-based regimens. Here we describe our institutional experience with adjuvant TV for patients with early-stage HER2+ BC. Methods: Clinicopathological characteristics, treatment details, and outcomes of patients with localized HER2+ BC treated with adjuvant TV from 2007 to 2021 at a large academic medical institution were collected. Study endpoints included invasive disease-free survival (IDFS), overall survival (OS), and safety/tolerability. IDFS and OS were measured from start date of TV treatment to date of event/last follow-up and date of death/last follow-up, respectively. Results: A total of 30 patients were treated with TV. All patients received trastuzumab at standard dosing and vinorelbine at a starting dose of 25 mg/m2 either on days 1/8 or on days 1/8/21 (weekly) of a 21-day cycle with four planned cycles. Median age at diagnosis was 59 years (range: 36–81). 90.3% of patients had anatomic pathologic stage IA BC and 9.7% stage IIA BC. Of the 30 patients, 24 of them opted to pursue TV due to concerns related to alopecia, neuropathy, and other toxicities, and 6 switched from treatment with TH to TV due to toxicities. Eight patients experienced neutropenia with no cases of febrile neutropenia. No patients experienced alopecia or long-term neuropathy. With a median follow-up of 68 months (5.7 years), the 5-year IDFS rate was 90.9%, with one local and one distant recurrence. The 5-year OS was 100%. Conclusions: Trastuzumab in combination with vinorelbine in the adjuvant, early-stage setting for low-risk HER2+ BC demonstrated clinical efficacy and appeared to be well tolerated. TV warrants further evaluation as an alternative regimen to TH for patients with early-stage HER2+ BC.

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Section: Discussionsupporting

confidence: 93%

Section: Discussionsupporting

confidence: 93%

Section: Introductionmentioning

confidence: 99%

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Adjuvant trastuzumab and vinorelbine for early-stage HER2+ breast cancer

et al. 2023

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“…At present, in addition to capecitabine, no relevant reports have been observed to evaluate the specific efficacy of pyrotinib combined with other chemotherapeutic drugs. According to the experience of trastuzumab, tegafur [19], paclitaxel [20], vinorelbine [21] and cemcitabinecan [22] also be selected for combination chemotherapy. Therefore, when we developed the combination chemotherapy regimen, we selected other drugs for patients who had previously used capecitabine and also achieved good results.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and Side Effects in HER2-Positive Advanced Breast Cancer Patients Treated with Pyrrotinib: A Real-World Study in China

Wang¹,

Meng²,

LI³

et al. 2021

annhematoloncol

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Background: Pyrotinib is a molecular and irreversible tyrosine kinase inhibitor independently developed in China, and its efficacy against HER2- positive breast cancer in the real world is not clear. In this study, we evaluated the efficacy and safety of pyrotinib in the treatment of HER2-positive advanced breast cancer based on real-world evidence. Materials and Methods: We designed a prospective observational study. Thirty-six patients with HER2-positive advanced breast cancer from a single medical center were included in the study from December 2018 to February 2021. All patients received the oral HER2 receptor inhibitor pyrotinib and received concurrent chemotherapy or endocrinotherapy. The follow-up endpoint is set as April 1, 2021. The primary endpoint is Objective Response Rate (ORR) and Disease Control Rate (DCR), and the secondary endpoint is Progression- Free Survival (PFS) and related side effects. Results: By the end point of follow-up, a total of 17 patients had progressed (including 6 deaths), and the progression-free survival rate was 52.78%. The median PFS was 13months (PFS range: 3-22 months). As the best response, 4 patients achieved CR, 20 patients achieved PR, 9 patients achieved SD, and 3 patient developed PD. The ORR was 66.67% and DCR was 91.67%. In the analysis, first-line pyrotinib treatment appeared to have higher ORR (88.88% vs 59.26%), but there was no significant difference. In addition, pyrotinib showed significant efficacy in patients with brain metastases, with an ORR of 42.85%. In terms of safety, the incidence of diarrhea was 80.55%, but only 4 patients had grade 3 diarrhea, which was tolerable after the drug dose was reduced; 1 patient had grade 4 neutropenia and grade 3 and thrombocytopenia, which were considered to be related to the chemotherapy drugs. The incidence of other adverse reactions was low, and all were grade 1 to 2. Conclusion: Pyrotinib combined with chemotherapy has a significant effect on HER2-positive breast cancer, and there is still a high ORR in patients who fail multiple lines of treatment. Side effects are overall controllable and safe.

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“…At the onset of the Phase I combination study in 2011, the preferred first-line chemotherapy regimens recommended by the National Comprehensive Cancer Network (NCCN) [ 3 ]—which combined TRA with one and/or two anticancer drugs, e.g., PTX [ 4 , 5 ], DTX [ 6 – 10 ], capecitabine [CAPE] [ 7 , 11 , 12 ], and vinorelbine [VNR] [ 10 , 13 , 14 ]—were conducted for patients with HER2-positive recurrent or metastatic breast cancer. The package inserts of these anticancer drugs describe the following as major AEs: (1) TRA: cardiomyopathy and anaphylactoid symptoms; (2) PTX: myelosuppression, hypersensitive reaction, and peripheral neuropathy; (3) DTX: myelosuppression, anaphylaxis, and nail disorders; (4) CAPE: dehydration, hand-foot syndrome, and hepatopathy; and (5) VNR: myelosuppression, interstitial pneumonia, pulmonary congestion, and phlebitis.…”

Section: Discussionmentioning

confidence: 99%

Long-term combination chemotherapy using eribulin and trastuzumab for three patients with human epidermal growth factor receptor 2-positive metastatic breast cancer

et al. 2016

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The combination chemotherapy regimen of eribulin (ERI) and trastuzumab (TRA)—the ERI-TRA regimen—has been shown to be highly tolerable for patients with recurrent or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer. However, no sufficient clinical evidence is available for the long-term safety profile of the regimen. We report on three patients in the Phase I combination study of the regimen, for whom the regimen could be conducted over the long term. Patient #1 was a 68-year-old woman and underwent the regimen until cycle 23. Patient #2 was a 61-year-old woman and underwent the regimen until cycle 27. Patient #3 was a 59-year-old woman and underwent the regimen until cycle 22. All these patients had undergone TRA-based combination therapy before the onset of the regimen. Any new categories of adverse events did not occur in association with the long-term combination chemotherapy. Neutropenia experienced by these patients was reversible and easily manageable by dose adjustment (interruption/delay and reduction). Neither increase in the risk of cardiomyopathy nor the worsening of peripheral neuropathy greater than grade 1 was found. The present regimen was suggested to be a novel chemotherapeutic option for patients with HER2-positive recurrent or metastatic breast cancer. The fact that the long-term ERI-TRA regimen was successfully conducted for these patients can be supplementary clinical information that is beneficial for clinical oncologists.

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The Trastuzumab and Vinorelbine Combination: An Alternative to Taxane-Based Chemotherapy for Early-Stage and Locally Advanced HER2-Positive Breast Cancer

Abstract: ConclusionsFor patients with non-metastatic breast cancer refusing alopecia, or for patients who are not candidates for standard chemotherapy, tv is a reasonable alternative to standard adjuvant chemotherapy.

Cited by 9 publications

References 14 publications

Adjuvant trastuzumab and vinorelbine for early-stage HER2+ breast cancer

Adjuvant trastuzumab and vinorelbine for early-stage HER2+ breast cancer

Efficacy and Side Effects in HER2-Positive Advanced Breast Cancer Patients Treated with Pyrrotinib: A Real-World Study in China

Long-term combination chemotherapy using eribulin and trastuzumab for three patients with human epidermal growth factor receptor 2-positive metastatic breast cancer

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