Abstract 235P
Background
CDK4/6 inhibitors (CDK4/6i) use has revolutionized the treatment of hormone receptor-positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) metastatic breast cancer. The choice of a specific CDK4/6i may be influenced by adverse events (AEs). Recently, the Italian Medicines Agency (AIFA) approved the possibility of switching between CDK4/6i for unacceptable toxicity.
Methods
With the support of the Italian Association of Medical Oncology (AIOM), we conducted a survey among 92 oncologists to assess the impact of AIFA's approval on patient management. The survey addressed treatment discontinuation for toxicity, exploring oncologists' experiences and future perspectives on CDK4/6i switch.
Results
The survey showed that 48% of participants were not surprised regarding AIFA’s decision, with 76% of respondents believing that this opportunity would significantly influence their treatment choices, enhancing AEs management for patients. Yet, 49% of respondents emphasized the need for more real world evidence on the safety and efficacy of CDK4/6i switch. 96% of respondents reported discontinuation rates between 0%-25% of patients, with constipation and hematological toxicity being the most frequent reasons for treatment discontinuation. The oncologists prescribing CDK4/6i switch reported that most of these patients were in first-line treatment (85%) and the most common switch to the second CDK4/6i that was most frequently initiated was palbociclib (69%), then abemaciclib (17%) and ribociclib (14%). Among those who started the second CDK4/6i at full dosage, 66% of patients did not require a dose reduction.
Conclusions
Our survey highlights the importance of allowing CDK4/6i switching, thus likely prompting oncologists to adapt their treatment choices, leading to better management of AEs for improving patients’ outcome.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
M. Lambertini: Financial Interests, Personal, Advisory Board: Roche, AstraZeneca, Lilly, Novartis, Pfizer, Exact Sciences, MSD, Seagen, Gilead; Financial Interests, Personal, Invited Speaker: Takeda, Sandoz, Ipsen, Libbs, Knight, Daiichi Sankyo, Lilly, Pfizer, Novartis, Roche; Financial Interests, Personal, Other, Travel grant to attend ASCO 2022: Gilead; Financial Interests, Institutional, Invited Speaker, 2-year research grant paid to my Institution: Gilead. M. Di Maio: Financial Interests, Personal, Advisory Board, Consultancy about clinical trial methodology and clinical trial results interpretation: Novartis; Financial Interests, Personal, Advisory Board, Consultancy about immunotherapy in SCLC: Roche; Financial Interests, Personal, Advisory Board, Consultancy about role and interpretation of patient-reported outcomes and quality of life in clinical trials: Takeda; Financial Interests, Personal, Advisory Board, Advisory board about the role of chemotherapy and hormonal treatment in hormone-sensitive prostate cancer: Janssen; Financial Interests, Personal, Advisory Board, Consultancy about the results obtained with lorlatinib and dacomitinib in advanced non-small cell lung cancer: Pfizer; Financial Interests, Personal, Advisory Board, Consultancy about role of osimertinib as adjuvant treatment of NSCLC: AstraZeneca; Financial Interests, Personal, Invited Speaker, Compensation for a talk and a document about role of patient-reported outcomes in clinical trials and in clinical practice, with a specific focus on lung cancer: Boehringer Ingelheim; Financial Interests, Personal, Advisory Board, Participation in advisory boards about olaparib in pancreatic cancer, about olaparib in prostate cancer, and about immunotherapy in lung cancer: Merck Sharp & Dohme; Financial Interests, Personal, Advisory Board, Consultant for the new indication of avelumab in urothelial cancer: Merck Serono; Financial Interests, Personal, Advisory Board, Advisory board about treatment of gastric cancer: Amgen; Financial Interests, Personal, Advisory Board, Lesson for the personnel of the drug company about quality of life, patient-reported outcomes and methodological aspects of clinical trials: GSK; Financial Interests, Institutional, Research Grant, Financial support and drug supply for the Meet-URO12 trial (niraparib as maintenance treatment of urothelial carcinoma after first-line treatment with platinum-based chemotherapy): Tesaro - GSK; Financial Interests, Institutional, Invited Speaker, Local PI of trial with tislelizumab in hepatocellular carcinoma: BeiGene; Financial Interests, Institutional, Invited Speaker, Local PI of a trial with cabozantinib and atezolizumab in advanced HCC: Exelixis; Financial Interests, Institutional, Invited Speaker, Local PI of a trial with atezolizumab and bevacizumab in advanced HCC: Roche; Financial Interests, Institutional, Invited Speaker, Local PI of trials with pembrolizumab in hepatocellular carcinoma: Merck Sharp & Dohme; Financial Interests, Institutional, Invited Speaker, Local PI of a trial with sasanlimab in NMI bladder cancer: Pfizer. G. Curigliano: Financial Interests, Personal, Invited Speaker: Roche, AstraZeneca, Daiichi Sankyo, Novartis, Pfizer, Pfizer; Financial Interests, Personal, Advisory Board: Roche, AstraZeneca, Daiichi Sankyo, Lilly, Pfizer, Veracyte, BMS, Merck, Exact Sciences, Celcuity; Financial Interests, Personal, Advisory Board, Advisory Board: Menarini, Gilead; Financial Interests, Personal, Other, Advisory Board: Ellipsis; Financial Interests, Institutional, Research Grant, Investigator Initiated Trial: Merck; Financial Interests, Institutional, Funding, Phase I studies: BMS, Novartis, AstraZeneca, Daiichi Sankyo, Roche, Blueprint Medicine, Kymab, Astellas, Sanofi, Philogen; Financial Interests, Institutional, Invited Speaker, Phase I clinical basket trial: Relay Therapeutics; Non-Financial Interests, Officer, Italian National Health Council as Advisor for Ministry of Health: Consiglio Superiore di Sanità; Non-Financial Interests, Advisory Role, Member of the Scientific Council. Patient advocacy association: Europa Donna; Non-Financial Interests, Advisory Role, Cancer Research Foundation: Fondazione Beretta; Non-Financial Interests, Member of Board of Directors, No compensation for this role. This a public national company for cancer prevention: Lega Italiana Lotta ai Tumori; Non-Financial Interests, Officer, Member of the Advisory Council: EUSOMA; Non-Financial Interests, Officer, ESMO Clinical Practice Guidelines Chair: ESMO; Non-Financial Interests, Member of Board of Directors, Chair of Clinical Practice Guidelines Committee: ESMO. C. Criscitiello: Financial Interests, Personal, Invited Speaker: Pfizer, Novartis, Eli Lilly, Roche, Gilead; Financial Interests, Personal, Advisory Board: MSD, Seagen, AstraZeneca, Daiichi Sankyo. All other authors have declared no conflicts of interest.