Literature DB >> 28548129

Central pathology review with two-stage quality assurance for pathological response after neoadjuvant chemotherapy in the ARTemis Trial.

Jeremy St John Thomas1, Elena Provenzano2,3,4, Louise Hiller5, Janet Dunn5, Clare Blenkinsop5, Louise Grybowicz6, Anne-Laure Vallier6, Ioannis Gounaris7, Jean Abraham2,3,8, Luke Hughes-Davies8,9, Karen McAdam9,10, Stephen Chan11, Rizvana Ahmad12, Tamas Hickish13,14, Stephen Houston15, Daniel Rea16, Carlos Caldas2,3,8,17, John Ms Bartlett18, David Allan Cameron19, Richard Laurence Hayward20, Helena Margaret Earl2,3,8.   

Abstract

The ARTemis Trial tested standard neoadjuvant chemotherapy±bevacizumab in the treatment of HER2-negative early breast cancer. We compare data from central pathology review with report review and also the reporting behavior of the two central pathologists. Eight hundred women with HER2-negative early invasive breast cancer were recruited. Response to chemotherapy was assessed from local pathology reports for pathological complete response in breast and axillary lymph nodes. Sections from the original core biopsy and surgical excision were centrally reviewed by one of two trial pathologists blinded to the local pathology reports. Pathologists recorded response to chemotherapy descriptively and also calculated residual cancer burden. 10% of cases were double-reported to compare the central pathologists' reporting behavior. Full sample retrieval was obtained for 681 of the 781 patients (87%) who underwent surgery within the trial and were evaluable for pathological complete response. Four hundred and eighty-three (71%) were assessed by JSJT, and 198 (29%) were assessed by EP. Residual cancer burden calculations were possible in 587/681 (86%) of the centrally reviewed patients, as 94/681 (14%) had positive sentinel nodes removed before neoadjuvant chemotherapy invalidating residual cancer burden scoring. Good concordance was found between the two pathologists for residual cancer burden classes within the 65-patient quality assurance exercise (kappa 0.63 (95% CI: 0.57-0.69)). Similar results were obtained for the between-treatment arm comparison both from the report review and the central pathology review. For pathological complete response, report review was as good as central pathology review but for minimal residual disease, report review overestimated the extent of residual disease. In the ARTemis Trial central pathology review added little in the determination of pathological complete response but had a role in evaluating low levels of residual disease. Calculation of residual cancer burden was a simple and reproducible method of quantifying response to neoadjuvant chemotherapy as demonstrated by performance comparison of the two pathologists.

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Year:  2017        PMID: 28548129     DOI: 10.1038/modpathol.2017.30

Source DB:  PubMed          Journal:  Mod Pathol        ISSN: 0893-3952            Impact factor:   7.842


  15 in total

1.  Residual proliferative cancer burden to predict long-term outcome following neoadjuvant chemotherapy.

Authors:  A Sheri; I E Smith; S R Johnston; R A'Hern; A Nerurkar; R L Jones; M Hills; S Detre; S E Pinder; W F Symmans; M Dowsett
Journal:  Ann Oncol       Date:  2014-10-30       Impact factor: 32.976

2.  Reproducibility of residual cancer burden for prognostic assessment of breast cancer after neoadjuvant chemotherapy.

Authors:  Florentia Peintinger; Bruno Sinn; Christos Hatzis; Constance Albarracin; Erinn Downs-Kelly; Jerzy Morkowski; Rebekah Gould; W Fraser Symmans
Journal:  Mod Pathol       Date:  2015-05-01       Impact factor: 7.842

3.  Efficacy of neoadjuvant bevacizumab added to docetaxel followed by fluorouracil, epirubicin, and cyclophosphamide, for women with HER2-negative early breast cancer (ARTemis): an open-label, randomised, phase 3 trial.

Authors:  Helena M Earl; Louise Hiller; Janet A Dunn; Clare Blenkinsop; Louise Grybowicz; Anne-Laure Vallier; Jean Abraham; Jeremy Thomas; Elena Provenzano; Luke Hughes-Davies; Ioannis Gounaris; Karen McAdam; Stephen Chan; Rizvana Ahmad; Tamas Hickish; Stephen Houston; Daniel Rea; John Bartlett; Carlos Caldas; David A Cameron; Larry Hayward
Journal:  Lancet Oncol       Date:  2015-05-11       Impact factor: 41.316

4.  A concordance correlation coefficient to evaluate reproducibility.

Authors:  L I Lin
Journal:  Biometrics       Date:  1989-03       Impact factor: 2.571

5.  Long-Term Prognostic Risk After Neoadjuvant Chemotherapy Associated With Residual Cancer Burden and Breast Cancer Subtype.

Authors:  W Fraser Symmans; Caimiao Wei; Rebekah Gould; Xian Yu; Ya Zhang; Mei Liu; Andrew Walls; Alex Bousamra; Maheshwari Ramineni; Bruno Sinn; Kelly Hunt; Thomas A Buchholz; Vicente Valero; Aman U Buzdar; Wei Yang; Abenaa M Brewster; Stacy Moulder; Lajos Pusztai; Christos Hatzis; Gabriel N Hortobagyi
Journal:  J Clin Oncol       Date:  2017-01-30       Impact factor: 44.544

6.  Effect of preoperative chemotherapy on local-regional disease in women with operable breast cancer: findings from National Surgical Adjuvant Breast and Bowel Project B-18.

Authors:  B Fisher; A Brown; E Mamounas; S Wieand; A Robidoux; R G Margolese; A B Cruz; E R Fisher; D L Wickerham; N Wolmark; A DeCillis; J L Hoehn; A W Lees; N V Dimitrov
Journal:  J Clin Oncol       Date:  1997-07       Impact factor: 44.544

7.  Standardization of pathologic evaluation and reporting of postneoadjuvant specimens in clinical trials of breast cancer: recommendations from an international working group.

Authors:  Elena Provenzano; Veerle Bossuyt; Giuseppe Viale; David Cameron; Sunil Badve; Carsten Denkert; Gaëtan MacGrogan; Frédérique Penault-Llorca; Judy Boughey; Giuseppe Curigliano; J Michael Dixon; Laura Esserman; Gerd Fastner; Thorsten Kuehn; Florentia Peintinger; Gunter von Minckwitz; Julia White; Wei Yang; W Fraser Symmans
Journal:  Mod Pathol       Date:  2015-07-24       Impact factor: 7.842

8.  Measurement of residual breast cancer burden to predict survival after neoadjuvant chemotherapy.

Authors:  W Fraser Symmans; Florentia Peintinger; Christos Hatzis; Radhika Rajan; Henry Kuerer; Vicente Valero; Lina Assad; Anna Poniecka; Bryan Hennessy; Marjorie Green; Aman U Buzdar; S Eva Singletary; Gabriel N Hortobagyi; Lajos Pusztai
Journal:  J Clin Oncol       Date:  2007-09-04       Impact factor: 44.544

9.  Quality assurance of pathology in clinical trials. The National Surgical Adjuvant Breast and Bowel Project experience.

Authors:  E R Fisher; J Costantino
Journal:  Cancer       Date:  1994-11-01       Impact factor: 6.860

10.  A central review of histopathology reports after breast cancer neoadjuvant chemotherapy in the neo-tango trial.

Authors:  E Provenzano; A-L Vallier; R Champ; K Walland; S Bowden; A Grier; N Fenwick; J Abraham; M Iddawela; C Caldas; L Hiller; J Dunn; H M Earl
Journal:  Br J Cancer       Date:  2013-01-08       Impact factor: 7.640

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  4 in total

1.  Sequencing of anthracyclines and taxanes in neoadjuvant and adjuvant therapy for early breast cancer.

Authors:  Milita Zaheed; Nicholas Wilcken; Melina L Willson; Dianne L O'Connell; Annabel Goodwin
Journal:  Cochrane Database Syst Rev       Date:  2019-02-18

2.  Lymphocyte density determined by computational pathology validated as a predictor of response to neoadjuvant chemotherapy in breast cancer: secondary analysis of the ARTemis trial.

Authors:  H R Ali; A Dariush; J Thomas; E Provenzano; J Dunn; L Hiller; A-L Vallier; J Abraham; T Piper; J M S Bartlett; D A Cameron; L Hayward; J D Brenton; P D P Pharoah; M J Irwin; N A Walton; H M Earl; C Caldas
Journal:  Ann Oncol       Date:  2017-08-01       Impact factor: 32.976

3.  Quality assurance guidance for scoring and reporting for pathologists and laboratories undertaking clinical trial work.

Authors:  Max Robinson; Jacqueline James; Gareth Thomas; Nicholas West; Louise Jones; Jessica Lee; Karin Oien; Alex Freeman; Clare Craig; Philip Sloan; Philip Elliot; Maggie Cheang; Manuel Rodriguez-Justo; Clare Verrill
Journal:  J Pathol Clin Res       Date:  2018-11-29

Review 4.  Assessing Pathologic Response in Resected Lung Cancers: Current Standards, Proposal for a Novel Pathologic Response Calculator Tool, and Challenges in Practice.

Authors:  Anjali Saqi; Kevin O Leslie; Andre L Moreira; Sylvie Lantuejoul; Catherine Ann Shu; Naiyer A Rizvi; Joshua R Sonett; Kosei Tajima; Shawn W Sun; Barbara J Gitlitz; Thomas V Colby
Journal:  JTO Clin Res Rep       Date:  2022-03-19
  4 in total

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