In oncologic monotherapy, SC compared to intravenous (IV) route brings advantages like patients’ (Pts) and healthcare professionals (HCP) preference and improved healthcare efficiency, thanks to reductions of both time and use of resources.
During adjuvant dual blockade for HER2 EBC, trained observers measured time used in various treatment activities for 3 cycles (2nd to 4th) of pertuzumab (Perjeta or P) IV and trastuzumab (Herceptin® or H) IV or SC (Group A: P-IV+H-IV; Group B: P-IV+H-SC) and later for subsequent 3 cycles (5th to 7th) of PH FDC SC (Phesgo). The objectives were to assess time saved by Pts and HCP and what resources were used with PH FDC SC versus P-IV+H-IV or P-IV+H-SC.
In 10 Spanish centres, 34 women were randomised (n=17 in Groups A and B). Per cycle, PH FDC SC saved 71% and 63% of Pts time in treatment room (-119 and -87 min, both p<0.0001) and 75% and 69% in chair (-121 and -90 min, both p<0.0001) compared with P-IV+H-IV and P-IV+H-SC, respectively. Active HCP time was reduced by 49% and 48% (-22.9 and -23.0 min, both p<0.0001), including preparation (-6.05 min p<0.0001 and -2.05 min p=0.1112) and administration (-16.9 min p=0.0006 and -20.8 min p<0.0001). Active times were reduced both for pharmacists (-2.10 min p=0.0185 and -1.46 min p=0.0488) and nurses (-18.3 min p=0.0004 and -20.0 min p<0.0001). PH FDC SC reduced use of consumables and avoided drug waste. Safety data up to cycle 7 (in 2025 ends 3-year follow-up) reported 20 Pts with 38 adverse events related to study treatments (only 2 Grade 3: diarrhoea and a serious [SAE] drug hypersensitivity).
PH FDC SC significantly saved Pts and HCP times and reduced use of healthcare resources. In dual therapies, the advantages of the SC route are added to those of fixed dose combination, versus administering drugs separately. Preliminary safety data indicated that the study treatments were overall well tolerated. Together with previous findings showing comparable efficacy and safety profiles and Pts preference of PH FDC SC versus P-IV+H-IV in (neo)adjuvant settings, these results encourage the use of PH FDC SC for dual blockade treatments.
EudraCT 2020-004241-36.
Medical writing services were provided by María Dolores Julián from Linical and supported by Roche Farma S.A.
Roche Farma S.A.
Roche Farma S.A.
S. González-Santiago: Financial Interests, Personal, Invited Speaker: Daiichi Sankyo, GSK, Pierre Fabre; Financial Interests, Personal, Advisory Role: Lilly, Seagen, AstraZeneca; Financial Interests, Personal, Other, Travel: Clovis, Pfizer. E. López-Miranda: Financial Interests, Personal, Advisory Role: AstraZeneca, Pfizer, Roche, Novartis; Financial Interests, Personal, Speaker’s Bureau: Roche, Novartis, Eisai, AstraZeneca; Financial Interests, Personal, Other, Travel: Roche, Novartis. S. Escrivá-De-Romaní: Financial Interests, Personal, Advisory Board: Roche, Daiichi Sankyo/AstraZeneca, Seagen; Financial Interests, Personal, Invited Speaker: Roche, Daiichi Sankyo/AstraZeneca, Pfizer; Financial Interests, Institutional, Invited Speaker: Roche, Synthon, Byondis, Lilly, MedSIR. B. Jiménez-Rodríguez: Financial Interests, Personal, Invited Speaker: Daiichi Sankyo, Lilly, Roche; Financial Interests, Personal, Advisory Role: Esteve; Financial Interests, Personal, Other, Travel: Daiichi Sankyo, Gilead, Roche. S. Antolín-Novoa: Financial Interests, Personal, Invited Speaker: Roche, Daiichi Sankio, Pierre Fabre, Lilly, Pfizer; Financial Interests, Personal, Advisory Role: Roche, Daiichi Sankio, Pierre Fabre, Lilly, Pfizer. L.A. Fernández-Morales: Financial Interests, Personal, Advisory Role: Novartis, Pfizer; Financial Interests, Personal, Principal Investigator: Roche, Novartis, Gilead Sciences; Financial Interests, Personal, Invited Speaker: Novartis, Pfizer, MSD, BMS, Pierre-Fabre. E. Galve-Calvo: Financial Interests, Personal, Advisory Board: Pfizer, Daiichi Sankyo, AstraZeneca, Gilead; Financial Interests, Personal, Expert Testimony: Pfizer, Novartis, Roche, Pierre Fabre, Eisai, Daiichi Sankyo, AstraZeneca, Gilead; Financial Interests, Personal, Invited Speaker: Pfizer, Daiichi Sankyo, AstraZeneca, Gilead; Other, Travel acomodation: Pfizer. I. Arroyo-Rivera: Financial Interests, Personal, Full or part-time Employment: Roche Farma S.A. C. García-Bernáldez: Financial Interests, Personal, Full or part-time Employment: Roche Farma S.A. J. Lagunar-Ruiz: Financial Interests, Personal, Full or part-time Employment: Roche Farma S.A. J. Gavilá-Gregori: Financial Interests, Personal, Invited Speaker: Novartis, Pfizer, Lilly, Roche, AstraZeneca, MSD; Financial Interests, Personal, Advisory Role: Novartis, Seagen, Roche, AstraZeneca, MSD. All other authors have declared no conflicts of interest.