Neoadjuvant and adjuvant trastuzumab in patients with HER2-positive locally advanced breast cancer (NOAH): follow-up of a randomised controlled superiority trial with a parallel HER2-negative cohort

Gianni, Luca; Eiermann, W.; Семиглазов, Владимир; Lluch, Aña; Tjulandin, Sergei; Zambetti, Milvia; Moliterni, Angela; Vázquez, Federico; Byakhov, M.; Lichinitser, Mikhail; Climent, Miguel Ángel; Ciruelos, Eva; Ojeda, B.; Mansutti, M.; Bozhok, A.A.; Magazzù, Domenico; Heinzmann, Dominik; Steinseifer, Jutta; Valagussa, Pinuccia; Baselga, José

doi:10.1016/s1470-2045(14)70080-4

Cited by 419 publications

(286 citation statements)

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“…Other trials have also shown that patients treated with neoadjuvant chemotherapy and trastuzumab and experiencing pCR have better survival outcomes compared to no pCR (16)(17)(18). The NOAH trial showed that patients treated with neoadjuvant trastuzumab and experiencing pCR had a better EFS compared to those without pCR after a median follow-up of 5·4 years (hazard ratio 0·17; 95%CI 0·08-0·38; p<0·0001) (19). In our trial, we demonstrated that pCR is correlated with better EFS and OS and that patients treated with the combination of lapatinib plus trastuzumab have the largest benefit of it, particularly in the hormone receptor negative cohort.…”

Section: Discussionsupporting

confidence: 52%

“…A pre-planned protocol efficacy analysis will be performed in 2.5 years. We identified full text of two randomized study of patients treated with neoadjuvant lapatinib plus trastuzumab combined with chemotherapy and one combined with endocrine therapy (18,19,28). The combination of lapatinib plus trastuzumab was also tested in an adjuvant trial recently presented (23).…”

Section: Discussionmentioning

confidence: 99%

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Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): survival outcomes of a randomised, open-label, multicentre, phase 3 trial and their association with pathological complete response

Azambuja

Holmes

Piccart‐Gebhart

et al. 2014

The Lancet Oncology

404

290

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Section: Discussionsupporting

confidence: 52%

Section: Discussionmentioning

confidence: 99%

Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): survival outcomes of a randomised, open-label, multicentre, phase 3 trial and their association with pathological complete response

Azambuja

Holmes

Piccart‐Gebhart

et al. 2014

The Lancet Oncology

404

290

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“…None of the 10 drugs granted conditional marketing authorisation were subsequently shown to improve quantity or quality of life. One of 68 authorised uses judged by the EMA to extend life at time of market authorisation failed to show such a benefit on longer follow-up according to the published report 41. Thus, with a minimum 3.3 years’ follow-up, in 26 of the 68 (38%) authorised drug indications there was a survival gain (including three of the seven drugs approved for use in a curative setting).…”

Section: Resultsmentioning

confidence: 99%

Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13

Davis

Naci

Gurpinar

et al. 2017

BMJ

487

415

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Objective To determine the availability of data on overall survival and quality of life benefits of cancer drugs approved in Europe. Design Retrospective cohort study. Setting Publicly accessible regulatory and scientific reports on cancer approvals by the European Medicines Agency (EMA) from 2009 to 2013. Main outcome measures Pivotal and postmarketing trials of cancer drugs according to their design features (randomisation, crossover, blinding), comparators, and endpoints. Availability and magnitude of benefit on overall survival or quality of life determined at time of approval and after market entry. Validated European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) used to assess the clinical value of the reported gains in published studies of cancer drugs. Results From 2009 to 2013, the EMA approved the use of 48 cancer drugs for 68 indications. Of these, eight indications (12%) were approved on the basis of a single arm study. At the time of market approval, there was significant prolongation of survival in 24 of the 68 (35%). The magnitude of the benefit on overall survival ranged from 1.0 to 5.8 months (median 2.7 months). At the time of market approval, there was an improvement in quality of life in seven of 68 indications (10%). Out of 44 indications for which there was no evidence of a survival gain at the time of market authorisation, in the subsequent postmarketing period there was evidence for extension of life in three (7%) and reported benefit on quality of life in five (11%). Of the 68 cancer indications with EMA approval, and with a median of 5.4 years’ follow-up (minimum 3.3 years, maximum 8.1 years), only 35 (51%) had shown a significant improvement in survival or quality of life, while 33 (49%) remained uncertain. Of 23 indications associated with a survival benefit that could be scored with the ESMO-MCBS tool, the benefit was judged to be clinically meaningful in less than half (11/23, 48%). Conclusions This systematic evaluation of oncology approvals by the EMA in 2009-13 shows that most drugs entered the market without evidence of benefit on survival or quality of life. At a minimum of 3.3 years after market entry, there was still no conclusive evidence that these drugs either extended or improved life for most cancer indications. When there were survival gains over existing treatment options or placebo, they were often marginal.

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“…Lapatinib as the second listed anti-HER2 target drug is combined with capecitabine, this has become the standard first-line treatment of advanced HER2-positive metastatic breast cancer patients (Geyer et al, 2006). For HER2 over-expressing breast cancer, preoperatively given target of anti-HER2 treatment can significantly inhibit the proliferation of tumor, reduce tumor residual after treatment and increase the probability of breast conserving surgery and improve resectability and for evaluation of tumor response to chemotherapy by changes in tumor size (Jackisch et al, 2015;Gianni et al, 2014;Badwe et al, 2011).…”

Section: Introductionmentioning

confidence: 99%

Lapatinib, trastuzumab or the combination added to neoadjuvant chemotherapy for breast cancer

Qin

et al. 2016

Bangladesh J Pharmacol

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trastuzumab or the combination added to neoadjuvant chemotherapy for breast cancer. Bangladesh J Pharmacol. 2016; 11: 863-68. Lapatinib, trastuzumab or the combination added to neoadjuvant chemotherapy for breast cancer Meta-analysisThis article was downloaded by you on: Dec 14, 2016 settings; results have been conflicting. So, to evaluate the efficacy of adding lapatinib to trastuzumab combined with neoadjuvant therapy for the treatment of HER2-positive breast cancer, a meta-analysis of all relevant published randomized clinical trials (RCTs) was performed. Materials and Methods Eligibility criteriaHave been published regarding the use of patients with HER2-positive breast cancer neoadjuvant chemotherapy combined with trastuzumab compared neoadjuvant chemotherapy combined with trastuzumab, lapatinib dual targeting drug efficacy and safety of stage II or III prospective random control research. The test group was neoadjuvant chemotherapy plus trastuzumab plus lapatinib. The control group was neoadjuvant chemotherapy plus trastuzumab. There was no restriction on neoadjuvant chemotherapy, but for the same study, the test group and the control group were the same as the new adjuvant chemotherapy, only anti-HER2 treatment was different. The primary outcome was a pathological complete response (pCR). Exclusion criteriai) The study of non-operative advanced breast cancer; ii) Non-prospective randomized controlled trial; iii) Baseline balance between the test group and the control group was poor, and they were not comparable between the two groups; iv) Study on the evaluation index of curative effect; v) High rate of loss of followup, more than 10% of the study; vi) The follow-up study was less than 2 years. Search strategyComputer retrieval PubMed, Medline, The Cochrane Library, Web of Science, Chinese journal full-text database and Wan Fang Medical journal full-text database, plus nearly 5 years of the important international conference on oncology records retrieval time was limited up to July in 2015. The language was not limited. When the same research had a number of literature reports, only the latest and most recent literature was evaluated. Key words were breast cancer, neoadjuvant, trastuzumab and lapatinib, breast cancer, neoadjuvant chemotherapy and according to the reference literature expand the search. Data extractionBy two researchers independently, encounter differences through discussion, access to the original data or consult the relevant experts to solve. Data extraction includes: The first author's name, year of publication, the number of cases could be evaluated the efficacy of intervention measures, and indicators, etc. Quality controlTo assess the validity of the included studies, according to the Cochrane handbook, we examined the sequence generation of allocation, allocation concealment, masking of participants, personnel and outcome assessors, incomplete outcome data, selective outcome reporting. Statistical analysisMeta software RevMan 5.0 was used for statistical analysis. For each i...

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Neoadjuvant and adjuvant trastuzumab in patients with HER2-positive locally advanced breast cancer (NOAH): follow-up of a randomised controlled superiority trial with a parallel HER2-negative cohort

Cited by 419 publications

References 18 publications

Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): survival outcomes of a randomised, open-label, multicentre, phase 3 trial and their association with pathological complete response

Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): survival outcomes of a randomised, open-label, multicentre, phase 3 trial and their association with pathological complete response

Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13

Lapatinib, trastuzumab or the combination added to neoadjuvant chemotherapy for breast cancer

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