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. Author manuscript; available in PMC: 2023 Aug 1.
Published in final edited form as: Lancet Oncol. 2022 Aug;23(8):e374–e384. doi: 10.1016/S1470-2045(22)00139-5

Table 2.

Statements on recurrent ovarian cancer

Statement 7 Categorisation by clinical and molecular factors
(Approval 33/33 groups)
1. Eligibility should be categorised and/or stratified according to:
  - Histology: high grade serous and high grade endometrioid (with aberrant p53 IHC) vs. others
  - BRCA1/2 mutation status
  - Number of prior lines of treatment
  - Exposure and response to prior treatments
  - Treatment-free interval from last platinum (TFIp)
  - Outcome of surgery for recurrent disease
2. Eligibility based only on the interval from last platinum treatment is discouraged.
Statement 8 Platinum-based regimens as reference arm
(Approval 32/33 groups, 1 opposed*)
1. Platinum-containing regimens should be the reference arm in patient populations where response to platinum is expected. These include patients with:
 - Tumours without progression during platinum or shortly following last platinum dose (e.g. within 12 weeks)
 - Tumours that have responded to the most recent platinum.
 - No prior platinum therapy
 - No residual tumour at the start of platinum therapy
2. Appropriate reference arms include:
 - Platinum-based combination regimens (carboplatin + pegylated liposomal doxorubicin preferred)
 - PARP inhibitor therapy can be an appropriate alternative reference arm in patients with BRCAm 1/2 who have received >2 prior platinum lines and who are PARPi naive.
3. Maintenance options in the reference arm should be based on study design and prior exposure
 - PARPi in those who have responded to platinum-based therapy.
 - Bevacizumab in combination with chemotherapy and as maintenance, including in those who have previously received a PARP inhibitor and/or bevacizumab.
4. Prior exposure to PARPi and/or bevacizumab should be included as stratification factors.
Information on duration of exposure and timing of progression (during vs following)
should be considered as inclusion or stratification factors.
Statement 9 Non-platinum regimens as reference arm
(Approval 31/33 groups, 2 opposed*)
1. Reference arms should contain non-platinum-based regimens when response to platinum is not expected:
 - Tumours that have progressed on platinum or early (e.g. within 12 weeks) following last platinum dose
 - Tumours not achieving a response to prior platinum
2. Potential reference arms may include:
 - Single agent chemotherapy, such as pegylated liposomal doxorubicin (PLD), weekly paclitaxel, gemcitabine, or topotecan
 - Incorporation of bevacizumab for those receiving PLD, weekly paclitaxel or topotecan.
3. Supportive care (without anti-cancer therapy) can be included as an option in patients who have received >4 treatment lines or where there are no standard of care options.
4. Patients with primary platinum refractory tumours (progressed on or within 12 weeks of first platinum treatment) constitute a specific patient cohort and should be enrolled in dedicated trials, or should be stratified if enrolled in trials for patients not suitable for platinum retreatment.
Statement 10 Biomarker directed trials may allow a broader population based on clinical and molecular factors (Approval 33/33 groups)
The reference arm of biomarker-driven trials may include both platinum and non-platinum regimens according to patient clinical characteristics, with appropriate stratification.
Statement 11 Secondary cytoreductive surgery
(Approval 32/33 groups, 1 abstain*)
1. Secondary cytoreduction is permitted prior to clinical trial enrolment and should be included as a stratification factor pre-randomisation, along with extent of residual disease.
2. Secondary cytoreduction should be considered in all patients with recurrent disease fulfilling criteria predictive of successful complete resection
3. Secondary cytoreduction as a component of protocol-directed management (post randomisation) would only be permitted if included within the trial design.
- When included as a component of protocol-directed therapy, secondary cytoreduction should be reserved for patients selected using a validated score (e.g. AGO score)