Roche 는 정말 약도 잘 만들지만, 그 보다도 약 파는 능력은 가히 둘째가라면 서러워하는 (second to none) 회사 인 듯.
Perjeta (Pertuzumab) 은 Herceptin (Trastuzumab) 과 동일하게 her2 에 결합해 signaling 을 저해 하는데, 일단은 결합 부위가 다르다.
APHINITY clinical trial 에 대해서는, ASCOpost 를 참고.
(Adjuvant Pertuzumab and Herceptin IN Initial TherapY in Breast Cancer)
APHINITY (NCT01358877/BO25126/BIG 4-11) is an international, phase III, randomized, double-blind, placebo-controlled, two-arm study evaluating the efficacy and safety of pertuzumab plus trastuzumab and chemotherapy compared to trastuzumab and chemotherapy as an adjuvant therapy in 4,805 people with operable HER2-positive early breast cancer.
People enrolled in the study underwent surgery and were randomized to one of two arms (1:1) to receive either:
- Six to eight cycles of chemotherapy (anthracycline-containing or non–anthracycline-containing regimen) with pertuzumab and trastuzumab, followed by pertuzumab and trastuzumab every 3 weeks for a total of 1 year of treatment.
- Six to eight cycles of chemotherapy (anthracycline-containing or non–anthracycline-containing regimen) with placebo and trastuzumab, followed by placebo and trastuzumab every 3 weeks for a total of 1 year of treatment.
Radiotherapy and/or endocrine therapy could be initiated at the end of adjuvant chemotherapy. The APHINITY study allowed for a range of standard chemotherapy regimens to be used and both lymph node–positive and lymph node–negative participants were eligible for enrollment. The primary efficacy endpoint of the APHINITY study is invasive disease–free survival. Secondary endpoints include cardiac and overall safety, overall survival, disease-free survival, and health-related quality of life.