^
Association details:
| Biomarker: | HER-2 positive |
|---|---|
| Cancer: | Biliary Tract Cancer |
| Drug: | Herzuma (trastuzumab-pkrb) (HER2 inhibitor) |
| Direction: | Sensitive |
Evidence:
Evidence Level:
Sensitive: C1 - Off-label
(Approved for Gastroesophageal Junction Adenocarcinoma)
New
Excerpt:
Herzuma in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease.
Source:
Title:
Trastuzumab plus FOLFOX for HER2-positive biliary tract cancer refractory to gemcitabine and cisplatin: a multi-institutional phase 2 trial of the Korean Cancer Study Group (KCSG-HB19-14)
Published date:
10/31/2022
Excerpt:
Ten patients had a partial response and 17 had stable disease; the overall response rate was 29·4% (95% CI 16·7-46·3) and the disease control rate was 79·4% (95% CI 62·9-89·9). Median progression-free survival was 5·1 months (95% CI 3·6-6·7); median overall survival was 10·7 (95%CI 7·9-not reached)....For HER2-positive biliary tract cancer, second-line or third-line trastuzumab biosimilar plus FOLFOX exhibited promising activity with acceptable toxicity...
Secondary therapy:
FOLFOX
DOI:
10.1016/S2468-1253(22)00335-1
Trial ID:
Source:
Title:
Trastuzumab plus FOLFOX for gemcitabine/cisplatin refractory HER2-positive biliary tract cancer: A multi-institutional phase II trial of the Korean Cancer Study Group (KCSG-HB19-14)
Published date:
06/02/2022
Excerpt:
The primary endpoint was met, with 29.4% (95%CI 15.1-47.5) ORR (PR n = 10), and 79.4% DCR. Median PFS was 5.1 months (95%CI 3.6-6.7)...For HER2-positive BTC, 2nd- or 3rd-line trastuzumab plus FOLFOX exhibited a promising efficacy…
DOI:
10.1200/JCO.2022.40.16_suppl.4096
Trial ID:
Source:
Title:
Feasibility of HER2-Targeted Therapy in Advanced Biliary Tract Cancer: A Prospective Pilot Study of Trastuzumab Biosimilar in Combination with Gemcitabine Plus Cisplatin
Published date:
01/06/2021
Excerpt:
The combination of trastuzumab-pkrb, an anti-HER2 monoclonal antibody, and GemCis resulted in high overall response (50%) and disease control (100%) rates in HER2-positive advanced BTC patients without new safety issues….The median follow-up duration of these patients was 10.5 months (95% CI, 5.3–13.7), the ORR was 17.2% with all partial responses and the DCR was 69.0%.
Secondary therapy:
cisplatin + gemcitabine
DOI:
10.3390/cancers13020161
