Open Access
CC BY 4.0 · Indian J Med Paediatr Oncol
DOI: 10.1055/s-0045-1812068
Original Article

A Retrospective Multicenter Real-World Study to Determine the Efficacy and Safety of PHESGO in HER2-Positive Breast Cancer from a Community Oncology Practice in Western India

Authors

  • Udip Maheshwari

    1   Department of Medical Oncology, MOC Cancer Care & Research Centre, Mumbai, Maharashtra, India
  • Vashishth Maniar

    1   Department of Medical Oncology, MOC Cancer Care & Research Centre, Mumbai, Maharashtra, India
  • Ashish Joshi

    1   Department of Medical Oncology, MOC Cancer Care & Research Centre, Mumbai, Maharashtra, India
  • Pritam Kalaskar

    1   Department of Medical Oncology, MOC Cancer Care & Research Centre, Mumbai, Maharashtra, India
  • Kshitij Joshi

    1   Department of Medical Oncology, MOC Cancer Care & Research Centre, Mumbai, Maharashtra, India
  • Disha Morzaria

    4   Department of Clinical Research, MOC Cancer Care & Research Centre, Mumbai, Maharashtra, India
  • Pradip Kendre

    1   Department of Medical Oncology, MOC Cancer Care & Research Centre, Mumbai, Maharashtra, India
  • Smit Sheth

    1   Department of Medical Oncology, MOC Cancer Care & Research Centre, Mumbai, Maharashtra, India
  • Chandrashekhar Pethe

    2   Department of Medical Oncology, MOC Cancer Care & Research Centre, Nashik, Maharashtra, India
  • Sonal Dhande

    2   Department of Medical Oncology, MOC Cancer Care & Research Centre, Nashik, Maharashtra, India
  • Seema Jagiasi

    1   Department of Medical Oncology, MOC Cancer Care & Research Centre, Mumbai, Maharashtra, India
  • Taha Sethjiwala

    3   Department of Medical Oncology, MOC Cancer Care & Research Centre, Indore, Madhya Pradesh, India
  • Krushna Chaudhari

    3   Department of Medical Oncology, MOC Cancer Care & Research Centre, Indore, Madhya Pradesh, India

Funding None.
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Abstract

Introduction

The treatment landscape for HER2-positive breast cancer has evolved with the introduction of targeted therapy using trastuzumab and pertuzumab. Though effective, intravenous (IV) administration presents challenges like infusion-related reactions and logistical issues, affecting patient adherence and quality of life. The advent of the subcutaneous (SC) formulation of PHESGO has emerged as a promising alternative, which enhances patient experience and adherence in the treatment of HER2-positive breast cancer.

Objectives

This study evaluates the efficacy, safety, and patient preference of PHESGO in a real-world setting.

Materials and Methods

This retrospective analysis included 30 patients with HER2-positive breast cancer receiving PHESGO as monotherapy or in combination with chemotherapy. Inclusion criteria encompassed patients aged 18 to 80 with comprehensive medical records and documented survival status. Data were extracted from electronic medical records to evaluate treatment efficacy, adverse events, and patient satisfaction, using validated Patient Preference and Therapeutic Antibody Satisfaction Questionnaire - Subcutaneous Injection (TASQ-SC) questionnaires.

Results

The median (interquartile range) age was 53.5 (18.0) years, with most patients at cancer stage IV (36.7%). PHESGO achieved an 86.7% objective response rate (ORR) and 76.7% [95% CI: 59.07–88.21] progression-free survival over a median survival duration of 496 days. Nearly 90% of the patients remained alive at the end of the observation period. Among neoadjuvant chemotherapy patients, a 75.0% pathological complete response rate was observed. All participants (100%) preferred SC administration, citing greater comfort and reduced clinic time, with 89.5% reporting minimal pain.

Conclusion

The findings indicate comparable efficacy and a favorable safety profile of PHESGO relative to traditional IV administration. The high levels of satisfaction and preference for SC administration suggest that PHESGO not only meets clinical efficacy standards but also meaningfully enhances the overall patient experience.

Patients' Consent

Written informed consent was obtained from all participants before their inclusion in the study.


Supplementary Material



Publikationsverlauf

Artikel online veröffentlicht:
09. Oktober 2025

© 2025. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/)

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  • References

  • 1 Horisawa N, Adachi Y, Takatsuka D. et al. The frequency of low HER2 expression in breast cancer and a comparison of prognosis between patients with HER2-low and HER2-negative breast cancer by HR status. Breast Cancer 2022; 29 (02) 234-241
  • 2 Schedin TB, Borges VF, Shagisultanova E. Overcoming therapeutic resistance of triple positive breast cancer with CDK4/6 inhibition. Int J Breast Cancer 2018; 2018 (01) 7835095
  • 3 Wahler J, Suh N. Targeting HER2 positive breast cancer with chemopreventive agents. Curr Pharmacol Rep 2015; 1 (05) 324-335
  • 4 Kast K, Link T, Friedrich K. et al. Impact of breast cancer subtypes and patterns of metastasis on outcome. Breast Cancer Res Treat 2015; 150 (03) 621-629
  • 5 Wu Q, Li J, Zhu S. et al. Breast cancer subtypes predict the preferential site of distant metastases: a SEER based study. Oncotarget 2017; 8 (17) 27990-27996
  • 6 Zimmerman BS, Esteva FJ. Next-generation HER2-targeted antibody-drug conjugates in breast cancer. Cancers (Basel) 2024; 16 (04) 800
  • 7 von Minckwitz G, Procter M, de Azambuja E. et al; APHINITY Steering Committee and Investigators. Adjuvant pertuzumab and trastuzumab in early HER2-positive breast cancer. N Engl J Med 2017; 377 (02) 122-131
  • 8 Gleeson JP, Keegan NM, Morris PG. Adding pertuzumab to trastuzumab and taxanes in HER2 positive breast cancer. Expert Opin Biol Ther 2018; 18 (03) 251-262
  • 9 Swain SM, Miles D, Kim SB. et al; CLEOPATRA Study Group. Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA): end-of-study results from a double-blind, randomised, placebo-controlled, phase 3 study. Lancet Oncol 2020; 21 (04) 519-530
  • 10 Moasser MM, Krop IE. The evolving landscape of HER2 targeting in breast cancer. JAMA Oncol 2015; 1 (08) 1154-1161
  • 11 Hong J, Park YH. Perioperative HER2 targeted treatment in early stage HER2-positive breast cancer. Ther Adv Med Oncol 2022; 14: 17 588359221106564
  • 12 Canino F, Barbolini M, De Giorgi U. et al. Safety and efficacy analysis of neoadjuvant pertuzumab, trastuzumab and standard chemotherapy for HER2-positive early breast cancer: real-world data from NeoPowER study. BMC Cancer 2024; 24 (01) 735
  • 13 Thompson LM, Eckmann K, Boster BL. et al. Incidence, risk factors, and management of infusion-related reactions in breast cancer patients receiving trastuzumab. Oncologist 2014; 19 (03) 228-234
  • 14 Mitchell H, Morrissey D. Intravenous versus subcutaneous trastuzumab: an economic and patient perspective. Br J Nurs 2019; 28 (10) S15-S20
  • 15 Al-Asadi O, Almusarhed M, Eldeeb H. Predictive risk factors of venous thromboembolism (VTE) associated with peripherally inserted central catheters (PICC) in ambulant solid cancer patients: retrospective single centre cohort study. Thromb J 2019; 17 (01) 2
  • 16 Swain SM, Tan AR, Gianni L. et al. Incidence and severity of anaphylaxis and hypersensitivity in trials of intravenous pertuzumab plus trastuzumab or the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection for HER2-positive breast cancer. Eur J Cancer 2023; 178: 70-81
  • 17 Fallowfield L, Osborne S, Langridge C, Monson K, Kilkerr J, Jenkins V. Implications of subcutaneous or intravenous delivery of trastuzumab; further insight from patient interviews in the PrefHer study. Breast 2015; 24 (02) 166-170
  • 18 Zambetti M, Montemurro F, Morandi P. et al. Safety profile of subcutaneous trastuzumab for the treatment of patients with HER2-positive early or locally advanced breast cancer: primary analysis of the SCHEARLY study. Eur J Cancer 2018; 105: 61-70
  • 19 Cicin İ, Oukkal M, Mahfouf H. et al. An open-label, multinational, multicenter, Phase IIIb study with subcutaneous administration of trastuzumab in patients with HER2-positive early breast cancer to evaluate patient satisfaction. Eur J Breast Health 2021; 18 (01) 63-73
  • 20 Pivot X, Verma S, Fallowfield L. et al; PrefHer Study Group. Efficacy and safety of subcutaneous trastuzumab and intravenous trastuzumab as part of adjuvant therapy for HER2-positive early breast cancer: final analysis of the randomised, two-cohort PrefHer study. Eur J Cancer 2017; 86: 82-90
  • 21 Tan AR, Im SA, Mattar A. et al; FeDeriCa Study Group. Fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection plus chemotherapy in HER2-positive early breast cancer (FeDeriCa): a randomised, open-label, multicentre, non-inferiority, phase 3 study. Lancet Oncol 2021; 22 (01) 85-97
  • 22 Nag S, Mane A, Dhobale M. et al. Efficacy and satisfaction among HER2 positive breast cancer patients undergoing subcutaneous injection of PHESGO along with chemotherapy: a case series. Asian Pacific J Environment Cancer 2024; 7 (01) 137-142
  • 23 O'Shaughnessy J, Sousa S, Cruz J. et al; PHranceSCa Study Group. Preference for the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in patients with HER2-positive early breast cancer (PHranceSCa): a randomised, open-label phase II study. Eur J Cancer 2021; 152: 223-232
  • 24 DuMond B, Patel V, Gross A, Fung A, Weber S. Fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in patients with HER2-positive breast cancer: a multidisciplinary approach. J Oncol Pharm Pract 2021; 27 (05) 1214-1221
  • 25 Pivot X, Spano JP, Espie M. et al. Long terms follow-up of the randomized MetaspHER study comparing intravenous versus subcutaneous trastuzumab in patients' with HER2-positive metastatic breast cancer. Clin Breast Cancer 2023; 23 (07) e412-e419
  • 26 Mathur P, Sathishkumar K, Chaturvedi M. et al; ICMR-NCDIR-NCRP Investigator Group. Cancer statistics, 2020: report from National Cancer Registry Programme, India. JCO Glob Oncol 2020; 6 (06) 1063-1075
  • 27 Theodore-Oklota C, Humphrey L, Wiesner C, Schnetzler G, Hudgens S, Campbell A. Validation of a treatment satisfaction questionnaire in non-Hodgkin lymphoma: assessing the change from intravenous to subcutaneous administration of rituximab. Patient Prefer Adherence 2016; 10: 1767-1776
  • 28 von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP. STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. PLoS Med 2007; 4 (10) e296
  • 29 Quartino AL, Hillenbach C, Li J. et al. Population pharmacokinetic and exposure-response analysis for trastuzumab administered using a subcutaneous “manual syringe” injection or intravenously in women with HER2-positive early breast cancer. Cancer Chemother Pharmacol 2016; 77 (01) 77-88
  • 30 Díaz-Redondo T, Lavado-Valenzuela R, Jimenez B. et al. Different pathological complete response rates according to PAM50 subtype in HER2+ breast cancer patients treated with neoadjuvant pertuzumab/trastuzumab vs. trastuzumab plus standard chemotherapy: an analysis of real-world data. Front Oncol 2019; 9: 1178
  • 31 Belin L, Tan A, De Rycke Y, Dechartres A. Progression-free survival as a surrogate for overall survival in oncology trials: a methodological systematic review. Br J Cancer 2020; 122 (11) 1707-1714
  • 32 Broglio KR, Quintana M, Foster M. et al. Association of pathologic complete response to neoadjuvant therapy in HER2-positive breast cancer with long-term outcomes: a meta-analysis. JAMA Oncol 2016; 2 (06) 751-760
  • 33 Wedam S, Fashoyin-Aje L, Gao X. et al. FDA approval summary: ado-trastuzumab emtansine for the adjuvant treatment of HER2-positive early breast cancer. Clin Cancer Res 2020; 26 (16) 4180-4185
  • 34 McCloskey C, Ortega MT, Nair S, Garcia MJ, Manevy F. A systematic review of time and resource use costs of subcutaneous versus intravenous administration of oncology biologics in a hospital setting. PharmacoEconom Open 2023; 7 (01) 3-36
  • 35 Gianni L, Pienkowski T, Im YH. et al. 5-year analysis of neoadjuvant pertuzumab and trastuzumab in patients with locally advanced, inflammatory, or early-stage HER2-positive breast cancer (NeoSphere): a multicentre, open-label, phase 2 randomised trial. Lancet Oncol 2016; 17 (06) 791-800
  • 36 Nakagaki S, Matsunuma R, Yamaguchi K. et al. The preferred premedication order to prevent infusion reactions in patients with breast cancer receiving pertuzumab plus trastuzumab and docetaxel. J Adv Med Med Res 2021; 33 (22) 24-30
  • 37 Jackisch C, Kim SB, Semiglazov V. et al. Subcutaneous versus intravenous formulation of trastuzumab for HER2-positive early breast cancer: updated results from the phase III HannaH study. Ann Oncol 2015; 26 (02) 320-325