BACKGROUND: The role of circulating tumor cells (CTCs) in HER2-positive breast cancer patients receivingneoadjuvant therapy is unclear. PATIENTS & METHODS: We describe the CTC detection rate, HER2 phenotyping and pathological complete response (pCR) in patients enrolled in the NeoALTTO phase III trial. Participation in the CTC sub-study was optional. CTC evaluation was performed centrally using CellSearch at baseline, week 2 and week 18 (prior to surgery) of neoadjuvant therapy. RESULTS: Samples for CTC analysis were available for 51/455 patients randomized. At baseline, week 2 and week 18, we detected ≥1 CTC/22.5 ml in 5/46 (11%), 4/41 (10%), and 5/31 (16%) patients and ≥1 HER2-positive CTC/22.5 ml in 2/46 (4%), 2/41 (5%), and 3/31 (10%) patients with evaluable samples, respectively. 11/51 patients (21%) had ≥1 CTC/22.5 ml in at least one time point. pCR was observed in 3/11 (27.3%) versus 17/40 (42.5%) patients with detectable and no detectable CTCs, respectively (p = 0.36). No pCR was observed in the three patients with detectable HER2-positive CTCs prior to surgery. CONCLUSION: Numerically lower pCR rates were observed in patients with detectable CTCs, yet the study remains underpowered. A meta-analysis of CTC studies in this setting is warranted.
RCT Entities:
BACKGROUND: The role of circulating tumor cells (CTCs) in HER2-positive breast cancerpatients receiving neoadjuvant therapy is unclear. PATIENTS & METHODS: We describe the CTC detection rate, HER2 phenotyping and pathological complete response (pCR) in patients enrolled in the NeoALTTO phase III trial. Participation in the CTC sub-study was optional. CTC evaluation was performed centrally using CellSearch at baseline, week 2 and week 18 (prior to surgery) of neoadjuvant therapy. RESULTS: Samples for CTC analysis were available for 51/455 patients randomized. At baseline, week 2 and week 18, we detected ≥1 CTC/22.5 ml in 5/46 (11%), 4/41 (10%), and 5/31 (16%) patients and ≥1 HER2-positive CTC/22.5 ml in 2/46 (4%), 2/41 (5%), and 3/31 (10%) patients with evaluable samples, respectively. 11/51 patients (21%) had ≥1 CTC/22.5 ml in at least one time point. pCR was observed in 3/11 (27.3%) versus 17/40 (42.5%) patients with detectable and no detectable CTCs, respectively (p = 0.36). No pCR was observed in the three patients with detectable HER2-positive CTCs prior to surgery. CONCLUSION: Numerically lower pCR rates were observed in patients with detectable CTCs, yet the study remains underpowered. A meta-analysis of CTC studies in this setting is warranted.
Authors: Ryan J O Dowling; Joseph A Sparano; Pamela J Goodwin; Francois-Clement Bidard; David W Cescon; Sarat Chandarlapaty; Joseph O Deasy; Mitch Dowsett; Robert J Gray; N Lynn Henry; Funda Meric-Bernstam; Jane Perlmutter; George W Sledge; Mangesh A Thorat; Scott V Bratman; Lisa A Carey; Martin C Chang; Angela DeMichele; Marguerite Ennis; Katarzyna J Jerzak; Larissa A Korde; Ana Elisa Lohmann; Eleftherios P Mamounas; Wendy R Parulekar; Meredith M Regan; Daniel Schramek; Vuk Stambolic; Timothy J Whelan; Antonio C Wolff; Jim R Woodgett; Kevin Kalinsky; Daniel F Hayes Journal: JNCI Cancer Spectr Date: 2019-08-10
Authors: Fanny Le Du; Takeo Fujii; Kumiko Kida; Darren W Davis; Minjeong Park; Diane D Liu; Weiguo Wu; Mariana Chavez-MacGregor; Carlos H Barcenas; Vicente Valero; Debu Tripathy; James M Reuben; Naoto T Ueno Journal: PLoS One Date: 2020-03-26 Impact factor: 3.240
Authors: Trevor T Price; Monika L Burness; Ayelet Sivan; Matthew J Warner; Renee Cheng; Clara H Lee; Lindsey Olivere; Karrie Comatas; John Magnani; H Kim Lyerly; Qing Cheng; Chad M McCall; Dorothy A Sipkins Journal: Sci Transl Med Date: 2016-05-25 Impact factor: 17.956