RESPONDER Trial - Diagnosis of pathological complete RESPonse by vacuum-assisted biOpsy after NeoaDjuvant chemotherapy in brEast canceR

• Applicant: Professor Dr. Jörg Heil
• Subject Area: Gynaecology and Obstetrics ; Hematology, Oncology
• Term: from 2016 to 2019
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 286676905

• Final Report Year: 2020

Final Report Abstract

Neoadjuvant systemic treatment succeeds to remove all cancer cells in up to 80% of women with breast cancer. In such cases, breast surgery, the gold standard for confirming residual cancer cells, may be unnecessary and overtreatment. However, except for surgery there is no other approach to reliably differentiate between residual tumor or no residual tumor after neoadjuvant treatment. We evaluated the ability of minimally invasive, image-guided biopsy to reliably diagnose residual cancer cells – aiming to avoid unnecessary breast surgery for these women in the future. This trial enrolled 452 women who underwent study-specific image-guided biopsy before guideline-adherent breast surgery. We aimed to show that that image-guided VAB fails to detect residual cancer cells after systemic treatment in less than 10%. Image-guided VAB failed to detect surgically confirmed cancer cells in 37 of 208 women (17.8%). However, several points should be considered: 1) In 19 of those cases (51.4%), failure was potentially avoidable. 2) Performing biopsy with the largest needle by volume resulted in no false-negative results. 3) Combining results of imaging and image-guided biopsy lowered the rate of missed cancer cells to 6.2%. Although the primary aim could not be reached, these results are crucial information for future research. Further refinements of the procedure seem necessary and possible to spare future patients without any residual disease after neoadjuvant treatment the morbidity-associated breast surgery.

Publications

• (2018). Is Breast Surgery Necessary for Breast Carcinoma in Complete Remission Following Neoadjuvant Chemotherapy? Geburtshilfe Frauenheilkd. 2018 Jan;78(1):48-53
  Richter H, Hennigs A, Schaefgen B, Hahn M, Blohmer JU, Kümmel S, Kühn T, Thill M, Friedrichs K, Sohn C, Golatta M, Heil J
  
• (2018): RESPONDER - diagnosis of pathological complete response by vacuumassisted biopsy after neoadjuvant chemotherapy in breast Cancer - a multicenter, confirmative, one-armed, intra-individually-controlled, open, diagnostic trial. BMC Cancer. 2018 Aug 25;18(1):851
  Heil J, Sinn P, Richter H, Pfob A, Schaefgen B, Hennigs A, Riedel F, Thomas B, Thill M, Hahn M, Blohmer JU, Kuemmel S, Karsten MM, Reinisch M, Hackmann J, Reimer T, Rauch G, Golatta M
  
• (2018): Vacuum-Assisted Biopsy to Diagnose a Pathological Complete Response in Breast Cancer Patients After Neoadjuvant Systemic Therapy. Ann Surg. 2018 Dec;268(6):e60-e61
  Heil J, Richter H, Golatta M, Sinn HP
  
• Abstract GS5-03: Diagnosing residual disease and pathologic complete response after neoadjuvant chemotherapy in breast cancer patients by image-guided vacuum-assisted breast biopsy: Results of a prospective multicenter trial. Cancer Res 2020;80(4 Supplement):GS5-03
  Heil J, Pfob A, Sinn H-PP, et al.
  
• Artificial intelligence to accurately identify breast cancer patients with a pathologic complete response for omission of surgery after neoadjuvant systemic therapy: An international multicenter analysis. J Clin Oncol 2020; 38: 565–565
  Pfob A, Sidey-Gibbons C, Tasoulis MK (…) Heil J
  
• Eliminating the breast cancer surgery paradigm after neoadjuvant systemic therapy: current evidence and future challenges. Ann Oncol 2020; 31: 61–71
  Heil J, Kuerer HM, Pfob A, et al.
  
• Patients should be the tipping point of individualizing breast cancer surgery. Ann Oncol 2020
  Heil J, Pfob A
  
• (2020): Diagnosing Pathologic Complete Response in the Breast after Neoadjuvant Systemic Treatment of Breast Cancer Patients by Minimal Invasive Biopsy. Annals of Surgery 2022 Mar 1;275(3):576-581
  Heil J, Pfob A, Sinn H-P, et al.