Nine weeks versus 1 year adjuvant trastuzumab in combination with chemotherapy: final results of the phase III randomized Short-HER study

Conte, Pierfranco; Frassoldati, Antonio; Bisagni, Giancarlo; Brandes, Alba Ariela; Donadio, Michela; Garrone, Ornella; Piacentini, Federico; Cavanna, Luigi; Giotta, Francesco; Aieta, Michele; Gebbia, Vittorio; Molino, Annamaria; Musolino, Antonino; Ferro, Antonella; Maltoni, Roberta; Danese, Saverio; Zamagni, Claudio; Rimanti, Anita; Cagossi, Katia; Russo, Antonio; Pronzato, P.; Giovanardi, Filippo; Moretti, G; Lombardo, Laura; Schirone, Alessio; Beano, Alessandra; Amaducci, Laura; Bajardi, Eugenia; Vicini, Roberto; Balduzzi, Sara; D’Amico, Roberto; Guarneri, Valentina

doi:10.1093/annonc/mdy414

Cited by 136 publications

(128 citation statements)

References 21 publications

(23 reference statements)

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“…Some support for a shorter treatment duration was provided by a small trial, in which 9 weeks of trastuzumab showed a benefit similar to that from 1 year of trastuzumab when given with standard chemotherapy . Several other trials failed to show noninferiority of the shorter trastuzumab duration (9 weeks or 6 months) …”

Section: Optimizing Schedules For Cancer Therapymentioning

confidence: 99%

“…64,65 Several other trials failed to show noninferiority of the shorter trastuzumab duration (9 weeks or 6 months). [66][67][68] The larger, phase 3 PHARE (Protocol for Herceptin as Adjuvant Therapy With Reduced Exposure) and PERSEPHONE (6 versus 12 months of adjuvant trastuzumab for HER2-positive early breast cancer) trials in HER2-positive, early breast cancer had similar designs and assessed the same clinical endpoints. 69,70 The final PHARE analysis, with a median follow-up of 7.5 years, failed to show that 6 months of trastuzumab was noninferior to 12 months of trastuzumab; the frequency of cardiac events was lower in the 6-month arm.…”

Section: Area Generic Biosimilarmentioning

confidence: 99%

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Enhancing global access to cancer medicines

Cortés

Peréz-García

Llombart-Cussac

et al. 2020

CA A Cancer J Clinicians

143

108

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Globally, cancer is the second leading cause of death, with numbers greatly exceeding those for human immunodeficiency virus/acquired immunodeficiency syndrome, tuberculosis, and malaria combined. Limited access to timely diagnosis, to affordable, effective treatment, and to high‐quality care are just some of the factors that lead to disparities in cancer survival between countries and within countries. In this article, the authors consider various factors that prevent access to cancer medicines (particularly access to essential cancer medicines). Even if an essential cancer medicine is included on a national medicines list, cost might preclude its use, it might be prescribed or used inappropriately, weak infrastructure might prevent it being accessed by those who could benefit, or quality might not be guaranteed. Potential strategies to address the access problems are discussed, including universal health coverage for essential cancer medicines, fairer methods for pricing cancer medicines, reducing development costs, optimizing regulation, and improving reliability in the global supply chain. Optimizing schedules for cancer therapy could reduce not only costs, but also adverse events, and improve access. More and better biomarkers are required to target patients who are most likely to benefit from cancer medicines. The optimum use of cancer medicines depends on the effective delivery of several services allied to oncology (including laboratory, imaging, surgery, and radiotherapy). Investment is necessary in all aspects of cancer care, from these supportive services to technologies, and the training of health care workers and other staff.

show abstract

Section: Optimizing Schedules For Cancer Therapymentioning

confidence: 99%

Section: Area Generic Biosimilarmentioning

confidence: 99%

Enhancing global access to cancer medicines

Cortés

Peréz-García

Llombart-Cussac

et al. 2020

CA A Cancer J Clinicians

143

108

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“…Trastuzumab (Herceptin), a monoclonal antibody against subdomain IV of the HER2extracellular domain (ECD), combined with chemotherapy can significantly improve the prognosis of HER2-positive BC patients compared with chemotherapy alone, which has been demonstrated in the Cochrane meta-analyses [7,8]. Furthermore, according to several large and long-term followup trials, one year of trastuzumab therapy plus chemotherapy has become the standard of care for HER2-positive early breast cancer (EBC) patients [9][10][11][12]. However, cases of drug resistance remain and about 30% of patients relapse after trastuzumab therapy and new approaches are required [10][11][12].…”

Section: Introductionmentioning

confidence: 99%

Dual HER2 Blockade versus a Single Agent in Trastuzumab-Containing Regimens for HER2-Positive Early Breast Cancer: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

et al. 2020

Journal of Oncology

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Purpose. Although trastuzumab is the standard of care for patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (EBC), drug resistance and disease relapse occur. erefore, we performed a meta-analysis to assess the efficacy and safety of trastuzumab-containing dual anti-HER2 therapy compared to trastuzumab alone. Methods. A systematic search was performed to identify eligible randomized controlled trials (RCTs). Main outcomes including event-free survival/invasive disease-free survival (EFS/iDFS), overall survival (OS), and safety were considered. Results. Ten RCTs were included (15,284 patients). Significant improvements were observed in both EFS/iDFS (HR 0.86, p � 0.0003) and OS (HR 0.86, p � 0.02) with trastuzumab-based dual anti-HER2 therapy, especially in adjuvant treatment, while in the neoadjuvant setting, dual-targeted therapy also achieved a substantial pathological complete response (pCR) benefit (HR 1.34, p � 0.0002). Subgroup analysis revealed that the EFS/iDFS benefit was slightly higher with trastuzumab plus pertuzumab or plus neratinib than trastuzumab plus lapatinib, while OS benefit was significant with trastuzumab plus lapatinib, but there were no subgroup differences (interaction test, p � 0.80 and 0.24, resp.). In addition, EFS/iDFS benefit was unrelated to hormone receptor status but pronounced in the lymph node-positive (LN+) subgroup, which should be interpreted cautiously for lacking interaction (p � 0.18). Besides, patients receiving dual therapy, especially with the lapatinib-containing regimen, experienced more toxicity, but no increase in cardiotoxicity. Conclusions. Despite being associated with more toxicity, trastuzumab-containing dual anti-HER2 therapy is superior to trastuzumab single agent for HER2-positive EBC independent of hormone receptor status. e correlation between survival and LN status needs further verification. Trastuzumab plus pertuzumab or plus neratinib is the preferred regimen with substantial efficacy and lower toxicity.

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“…In the past decade, multiple trials, including two phase 3 randomised trials, 7,8 one three-group phase 2 trial, 2 and two single-group phase 2 trials, 9,10 have found an excellent therapeutic index associated with novel, anthracycline-free regimens. Additionally, five studies [11][12][13][14][15][16] evaluated whether a shorter duration of trastuzumab is non-inferior to the standard year. Non-inferiority could not be concluded in the first four studies; [11][12][13][14] thus, the debate appeared to be closed.…”

Section: Is the Duration Of Adjuvant Trastuzumab Debate Still Clinicamentioning

confidence: 99%

Is the duration of adjuvant trastuzumab debate still clinically relevant?

Hurvitz

2019

The Lancet

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Nine weeks versus 1 year adjuvant trastuzumab in combination with chemotherapy: final results of the phase III randomized Short-HER study

Cited by 136 publications

References 21 publications

Enhancing global access to cancer medicines

Enhancing global access to cancer medicines

Dual HER2 Blockade versus a Single Agent in Trastuzumab-Containing Regimens for HER2-Positive Early Breast Cancer: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Is the duration of adjuvant trastuzumab debate still clinically relevant?

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