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EP290/#820  Intermittent PARP inhibitor regimen in ovarian cancer (IPIROC): origin and feasibility of implementing a proof-of-concept exploratory study
  1. Asima Mukhopadhyay1,2,
  2. Tanushri Ghosh1,
  3. Daity Bhattacharjee1,
  4. Dona Chakraborty1,
  5. Rama Gupta1,
  6. Indrani Roychowdhury3,
  7. Puja Chatterjee4,
  8. Manisha Vernekar4,
  9. Rahul Roy Chowdhury5 and
  10. Ipiroc Study Group1
  1. 1Kolkata Gynecological Oncology Trials and Translational Research Group, Gynecological Oncology, Kolkata, India
  2. 2Newcastle University, Population Health Sciences Institute, Newcastle, UK
  3. 3Jawaharlal Nehru University, Economics, New Delhi, India
  4. 4Chittaranjan National Cancer Institute, Gynecological Oncology, Kolkata, India
  5. 5Saroj Gupta Cancer Centre and Research Institute, Gynecological Oncology, Kolkata, India


Introduction Availability/affordability and toxicity of PARP inhibitors (PARPi) for ovarian cancer treatment represent an unmet clinical need in LMICs, especially in women with anaemia/low-BMI. Through a CRUK/DBT-India-funded project, we generated proof-of-concept preclinical data showing durable parp inhibitory action after single dose rucaparib >72 hours. An academic/exploratory clinical feasibility study was planned for de-escalation/optimal scheduling, under GCIG mentorship (Sponsor: KolGOTRG).

Methods Institutional ethical approval was obtained. Patient-public-involvement workshops were held for assessing consumer preference/acceptance and willingness-to-pay. Platinum-sensitive (>3 months PFI) recurrent HGSC ovarian cancer patients were invited to participate, if deemed eligible for PARPi treatment. Bi-weekly rucaparib-generic (1200 mg, 2 days/week, 72hours apart) was administered orally for 12 weeks. Tolerability/toxicity/QOL and response-rate was assessed, followed by physician’s-choice of treatment/patients’-preference for continuation of intermittent regimen. PBMC was extracted and stored at 0/24/72/168 hours after the 1st rucaparib dose for future PK/PD studies. Barrier identification for implementing a dose de-escalation study was conducted using EASE model.

Results Of the 8 patients enrolled till April 2023, 3 women with large volume disease/ascites progressed at 12 weeks. 4 women continued till 24 weeks: 3 of them expressing willingness for continuing at 58, 52 and 48 weeks respectively due to favourable tolerability/QOL/response. No grade-3 haematological toxicity was recorded. Further 3 women on daily PARPi maintenance therapy, requiring dose de-escalation due to toxicity/affordability, opted for this regimen (outside study) and remain disease/toxicity free at >6 months.

Conclusion/Implications Provider/referral bias mitigation and advocacy, incorporation of patients’ preference and involving policymakers are important in designing future novel efficacy studies for dose de-escalation in LMICs.

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