A Phase II Randomized Study of Lapatinib Combined With Capecitabine, Vinorelbine, or Gemcitabine in Patients With HER2-Positive Metastatic Breast Cancer With Progression After a Taxane (Latin American Cooperative Oncology Group 0801 Study)

Gómez, Henry Leonidas; Neciosup, Silvia P.; Tosello, C.; Mano, Max S.; Bines, José; Ismael, Gustavo; Santi, Patrícia Xavier; Pinczowski, Hélio; Neron, Yeni Verónica; Fanelli, Marcello Ferretti; Fein, Luis; Sampaio, Carlos Eduardo Peres; Lerzo, Guillermo; Capó, Adolfo; Zarbá, Juan José; Blajman, C.; Varela, Mirta; Martínez-Mesa, Jeovany; Werutsky, Gustavo; Barrios, Carlos H.

doi:10.1016/j.clbc.2015.10.005

Cited by 20 publications

(27 citation statements)

References 29 publications

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“…The most common grade 3 and 4 adverse events were hand-foot syndrome (18%), diarrhea (6-9%) and increased alanine aminotransferase/aspartate aminotransferase (4-13%) and neutropenia (36-47%). Progression-free survival and toxicity also matched with those from other studies of lapatinib-capecitabine and lapatinib-vinorelbine in similar populations [98].…”

Section: Hormonotherapy and Anti-her2 Therapysupporting

confidence: 73%

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Genetics, Tumor Features and Treatment Response of Breast Cancer in Latinas

Castañeda

Castillo

Villarreal‐Garza

et al. 2018

Breast Cancer Manag.

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Practice pointsr Latinas with breast cancer have been associated with lower prevalence and higher mortality rates. r The access to healthcare system for Latinas has been described as lower than for white women. r Rates of grade III and triple-negative phenotype breast cancer are higher for Latinas than for white women. r BRCA mutation prevalence appears to be higher in Latinas than white women in the American population. r Distribution of BRCA mutation differs by country in Central, Latin America or Caribbean and recurrent mutations have been described in Mexico. r Finally, evaluated information about treatment efficacy and toxicity in Latinas with breast cancer indicate similar effects than in the white race.Breast cancer is a heterogeneous and genetic disease that has variability according to ethnicity and race with respect to incidence, clinical characteristics and prognosis. The incidence of breast cancer is lower but mortality is higher in Latinas than Caucasians in the US series. Risk factors appear to have different prevalence and impact in Latinas. Breast cancer in Latinas has particular clinic-pathological features including younger age, higher rates of triple-negative subtype and advanced stages. Molecular studies find that Latinas from every region have a specific BRCA incidence and a recurrent mutation, as well as differences in activity of molecular pathways. Treatment response rates and toxicity have also been compared, and no difference was found between Latinas and other ethnic groups.

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Section: Hormonotherapy and Anti-her2 Therapysupporting

confidence: 73%

“…The overall response rate (ORR) went from 41 to 56% in the capecitabine, vinorelbine or gemcitabine arm [98] which compares with an ORR on previously published data of 11.1-59.3% [99]. The median progression-free survival went from 7 to 9 months.…”

Section: Hormonotherapy and Anti-her2 Therapymentioning

confidence: 63%

Genetics, Tumor Features and Treatment Response of Breast Cancer in Latinas

Castañeda

Castillo

Villarreal‐Garza

et al. 2018

Breast Cancer Manag.

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“…Though the direct comparison was not inappropriate, our analysis suggested that continued use of trastuzumab in the basis of standard LX treatment among patients had progression on trastuzumab may provide benefit. LACOG 0801 study investigated the efficacy and safety of lapatinib combined with capecitabine (LX), vinorelbine (V), or gemcitabine (G) in patients with HER2+ MBC with progression after a taxane (20). The results show that LX has similar efficacy with the other 2 arms, though LV has a more numerically longer median PFS and OS (20).…”

Section: Discussionmentioning

confidence: 99%

“…LACOG 0801 study investigated the efficacy and safety of lapatinib combined with capecitabine (LX), vinorelbine (V), or gemcitabine (G) in patients with HER2+ MBC with progression after a taxane (20). The results show that LX has similar efficacy with the other 2 arms, though LV has a more numerically longer median PFS and OS (20). Our results also showed that TL combined with capecitabine had a numerically longer median PFS than vinorelbine, similar to previously reported in LACOG0801 study, suggesting that the two regimens seem to be active combinations in HER2+ MBC.…”

Section: Discussionmentioning

confidence: 99%

Real-World Data of Triplet Combination of Trastuzumab, Lapatinib, and Chemotherapy in HER2-Positive Metastatic Breast Cancer: A Multicenter Retrospective Study

Gong

et al. 2020

Front. Oncol.

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Introduction: Combination of trastuzumab (T) and lapatinib (L) has been showed to significantly improve the prognosis of HER2+ heavily pretreated metastatic breast cancer (MBC). Whether TL combined chemotherapy (TLC) can further improve the efficacy in HER2+ MBC remains to be further studied. The aim of the study was to report the first real-world data of TLC in HER2+ MBC, including the efficacy, safety and treatment patterns.Methods: Patients with HER2+ MBC treated with TLC in 5 institutions of China from September 2013 to July 2019 were included. Progression free survival (PFS), objective response rate (ORR), overall survival (OS), toxicity profile and treatment pattern were reported.Results: A total of 285 patients were included. 88.8% were exposed to trastuzumab and 49.2% received 2 or more lines of systematic therapy before TLC previously. The most common chemotherapy regimens combined with TL were capecitabine (40.7%) and vinorelbine (21.4%) and almost 1/3 received maintenance treatment after TLC. Median PFS was 10.9 months while patients received TLC as first line treatment showed longest median PFS of 20.7 months. Patients pretreated with trastuzumab showed a median PFS of 10.2 months. In patients who pretreated with trastuzumab, the continuation of trastuzumab on the basis of standard lapatinib plus capecitabine had a median PFS of 11.3 months. TL combined with capecitabine or vinorelbine showed no significant difference in median PFS, though TL combined with capecitabine had numerically prolongation (11.4 vs. 8.5 months, p = 0.231). Patients had brain metastasis (BM) also showed a median PFS (intracranial and extracranial lesions considered) of 10.6 months.Li et al. Real-World Data of TLCLines of systematic metastatic treatment was an independent predictive factor of PFS. The median OS was not reached. Two hundred and seventy seven patients were included in ORR analysis. ORR was 42.6%. Toxicities of triplet combinations were tolerable and the most common grade 3 and 4 adverse events were neutropenia (16.8%).Conclusions: TLC demonstrated promising effects and tolerable safety in HER2+MBC, even in patients with BM, providing a theoretical basis for clinical practice.Clinical Trial Registration: ClinicalTrials.gov, Identifier: NCT04001634.

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“…Furthermore, vinorelbine has been shown to be well tolerated in patients, with noncumulative granulocytopenia and neurotoxicity as the main dose-limiting toxicities. In several studies, the vinorelbine-based regimen showed significant antitumor activity and good tolerability for anthracycline- and taxane-pretreated ABC patients [6,7,8]. …”

Section: Introductionmentioning

confidence: 99%

Comparison of the Therapeutic Efficacy of the Early and the Delayed Use of Vinorelbine-Based Regimens for Patients with Advanced Breast Cancer

Wang

Liu²,

Jia³

et al. 2016

Chemotherapy

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Background: The aim of this study was to evaluate the efficacy of vinorelbine-based regimens as first-, second- and more-line therapies in advanced breast cancer (ABC) and to analyze the best timing of vinorelbine treatment. Methods: A total of 71 ABC patients were retrospectively reviewed. Of these, 35 patients were treated with vinorelbine-based regimens as first-line chemotherapy, and 36 patients were treated with vinorelbine-based regimens as second-line or more-line therapy. The primary end point of the study was progression-free survival (PFS). Results: No difference was found in baseline characteristics between the two groups (p > 0.1 for all comparisons). There was a significant difference in the objective response rate (ORR; p = 0.006) and clinical benefit rate (CBR; p = 0.013) between the first-line group and the second- or more-line groups. In the vinorelbine first-line group, the ORR was 68.6% (24 patients), and in the second-line or more-line groups the ORR was 36.1% (13 patients). A significant difference in PFS between the first-line group and the second-line or more-line groups was also observed (p = 0.030). The median PFS in the overall population was 6.3 ± 1.32 months (95% CI 3.69-8.90). The median PFS was 11.1 ± 3.76 months (95% CI 3.73-18.47) in the first-line group compared with 5.2 ± 1.35 months (95% CI 2.54-7.85) in the second-line or more-line groups. In patients treated with vinorelbine-trastuzumab combination as the first-line therapy, a complete response was observed in 1 patient (12.5%) and partial response in 5 patients (62.5%), giving an ORR of 75.0%. Progressive disease was observed in 1 patient (12.5%), and stable disease in 1 patient (12.5%), leading to a CBR of 87.5%. The median PFS was 13.8 ± 2.75 months (95% CI 8.42-19.18), and median OS was 37.0 ± 11.6 months (95% CI 14.18-59.82). No significant difference was found in overall survival (OS) between the groups (p = 0.612). Conclusion: For ABC patients, no significant difference in median OS was found between the early use and delayed use of vinorelbine-based regimens, but the short-term efficacy and PFS of vinorelbine-based regimens were significantly better in the early use group than in the delayed use group.

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A Phase II Randomized Study of Lapatinib Combined With Capecitabine, Vinorelbine, or Gemcitabine in Patients With HER2-Positive Metastatic Breast Cancer With Progression After a Taxane (Latin American Cooperative Oncology Group 0801 Study)

Abstract: LV and LG seem to be active combinations in patients with HER2(+) MBC after taxane failure. The overall toxicity was manageable in all regimens.

Cited by 20 publications

References 29 publications

Genetics, Tumor Features and Treatment Response of Breast Cancer in Latinas

Genetics, Tumor Features and Treatment Response of Breast Cancer in Latinas

Real-World Data of Triplet Combination of Trastuzumab, Lapatinib, and Chemotherapy in HER2-Positive Metastatic Breast Cancer: A Multicenter Retrospective Study

Comparison of the Therapeutic Efficacy of the Early and the Delayed Use of Vinorelbine-Based Regimens for Patients with Advanced Breast Cancer

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