Analysis of the Clinical Experience With Rucaparib in the Rucaparib Access Program (RAP) in Spain - A GEICO Study

Primary outcomes

1. Number of Participants With Relevant Co-morbidities

   Time frame: 0 months - Measurements were done at baseline

   Patient characteristics and medical history Detected diseases include: arterial hypertension, diabetes melliutus, COPD, ischemic cardiomyopathy, cerebrovascular disease, obesity, etc.

   Measurements were done at baseline

2. Other Previous Cancers?

   Time frame: 0 months - Measurements were done at baseline

   Patient characteristics and medical history. Descriptive statistics: Other cancers present during trial including endometrial, breast , colorrectal, lung or other cancers Measurements were done at baseline

3. Family History of Cancers?

   Time frame: 0 months - Measurements were done at baseline

   Patient characteristics and medical history Family history of other cancers including ovarian, breast and others Measurements were done at baseline

4. FIGO STAGE

   Time frame: 0 months - Measurements were done at baseline

   Stage = tumor size and location; higher stage = more spread metastasis I Tumor confined to the corpus uteri IA No or less than half myometrial invasion IB Invasion equal to or more than half of the myometrium IC IA+IB + ascites IC1 surgical spill IC2 Capsule rupture before surgery or tumor on ovarian surface II Tumor invades cervical stroma, but does not extend beyond the uterus III Local and/or regional spread of the tumor IIIA Tumor invades the serosa of the corpus uteri and/or adnexae IIIA2 involvement of uterine subserosa or spread through uterine serosa IIIB Vaginal involvement and/or parametrial involvement IIIC Metastases to pelvic and/or para-aortic lymph nodes IIIC1 Positive pelvic nodes IIIC2 Positive para-aortic nodes with or without positive pelvic lymph nodes IV Tumor invades bladder and/or bowel mucosa, and/or distant metastases IVA Tumor invasion of bladder and/or bowel mucosa IVB Distant metastasis (intra-abdominal metastases and/or inguinal nodes)

5. Tumor Histology

   Time frame: 0 months - Measurements were done at baseline

   Patient characteristics and medical history Tumor histology history Measurements were done at baseline

6. BCRA Status

   Time frame: 0 months - Measurements were done at baseline

   Patient characteristics and medical history mutational status (BRCA 1/2 [germline/somatic] and in other HRR genes) Measurements were done at baseline

7. Deficiencies in Other Genes Involved in Homologous Recombination

   Time frame: 0 months - Measurements were done at baseline

   Patient characteristics and medical history Other HRR deficiencies including RAD51C, RAD51D, PALBB2, BRIP1, CHEK1, CHEK2, BARD1, FAM175A, NEN, ATM, EMSY and others Measurements were done at baseline

8. Surgeries Before Rucaparib

   Time frame: 0 months - Measurements were done at baseline

   Patient characteristics and medical history Total number of surgeries per patient before treatment started Measurements were done at baseline

9. Previous Lines

   Time frame: 0-24 months

   Patient characteristics and medical history:

   Prior lines of platinum-based chemotherapy

10. PARPi Before Rucaparib

    Time frame: 0 months - Measurements were done at baseline

    Patient characteristics and medical history:

    PARPi treatment before rucaparib Measurements were done at baseline

11. Average Dose of Rucaparib Received Per 12 Hours

    Time frame: 0-12 months

    Rucaparib dosing data Descrption: average dose of rucaparib administered (mg/12h)

12. Rucaparib Drug Exposure

    Time frame: 0-24 months

    Rucaparib dosing data: mean starting dose, number of dose reductions, reasons for reductions, number of treatment discontinuations, reasons for discontinuations, duration of treatment, and switching of maintenance therapy to another PARP inhibitor (including reasons for switching).

    Rucaparib drug exposure in months Patient 14-001 has been eliminated for not following the treatment scheme

13. Dose Reductions

    Time frame: 0-12 months

    Rucaparib dosing data: mean starting dose, number of dose reductions, reasons for reductions, number of treatment discontinuations, reasons for discontinuations, duration of treatment, and switching of maintenance therapy to another PARP inhibitor (including reasons for switching).

    Specific description: How many dose reductions had to be conducted on each patient

    *Patient 14-001 from treatment group has been eliminated by not following the tratment scheme

14. Number of Dose Interruptions

    Time frame: 0-12 months

    Rucaparib dosing data: mean starting dose, number of dose reductions, reasons for reductions, number of treatment discontinuations, reasons for discontinuations, duration of treatment, and switching of maintenance therapy to another PARP inhibitor (including reasons for switching).

    Specific description: How many dose interruptions had to be conducted on each patient

    *Patient 14-001 from treatment group has been eliminated by not following the tratment scheme

15. Duration of Response (DoR)

    Time frame: 0-36 months

    Rucaparib efficacy data: best response rates in the treatment indication patients, duration of response and PFS in the treatment indication patients, PFS in the maintenance indication patients, radiological response to chemotherapy in maintenance patients (and impact of response on patient evolution).

    For maintenance patients: Duration of response has been calculated taking into account the date of CR or RP prior to RAP until progression (on last follow date) during Rucaparib as a maintenance treatment.

    For treatment patients: Duration of response has been calculated taking into account the best response date (PR or CR) during Rucaparib until progression of follow-up date (Only patients with PR or CR as best overall response)

16. End of Treatment

    Time frame: 0-24 months

    Rucaparib dosing data: mean starting dose, number of dose reductions, reasons for reductions, number of treatment discontinuations, reasons for discontinuations, duration of treatment, and switching of maintenance therapy to another PARP inhibitor (including reasons for switching).

    Description: Rucaparib exposure termination (reasons)

17. Objective Response Rate (ORR)

    Time frame: 0-24 months

    Rucaparib efficacy data ORR: Confirmed best overall tumor response of CR or PR according to RECIST v1.1 or Response and normalization or Response according to Rustin criteria. The RECIST v1.1 answer prevailed over the Rustin criterion answer except where RECIST is 'Not assessable' and Rustin criterion is different than 'Not assessable'.

    ORR was calculated only on the treatment population and not on the maintenance population.

    *This measurement was only taken in participants from the treatment group as these present an active disease, therefore Rucaparib was administered in order to reduce tumoral charge or control tumor progression. On the other hand, participants from the maintenance group have already responded to previous treatments, and rucaparib was administered I order to maintain response rate and/or delay progression, which was measured using "free-progression survival".

18. Progression-free Survival (PFS)

    Time frame: 0-24 months

    Rucaparib efficacy data: best response rates in the treatment indication patients, duration of response and PFS in the treatment indication patients, PFS in the maintenance indication patients, radiological response to chemotherapy in maintenance patients (and impact of response on patient evolution).

    It represents the length of time during and after treatment that a patient lives with the disease, but without it getting worse.

19. Radiological Best Overall Response

    Time frame: 0-24 months

    Rucaparib efficacy data Radiological best overall response - Only 19 radiologically evaluable patients (treatment group only)

    *This measurement was only taken in participants from the treatment group as these present an active disease, therefore Rucaparib was administered in order to reduce tumoral charge or control tumor progression. On the other hand, participants from the maintenance group have already responded to previous treatments, and rucaparib was administered I order to maintain response rate and/or delay progression, which was measured using "free-progression survival".

20. Biological Best Overall Response

    Time frame: 0-24 months

    Rucaparib efficacy data: best response rates in the treatment indication patients, duration of response and PFS in the treatment indication patients, PFS in the maintenance indication patients, radiological response to chemotherapy in maintenance patients (and impact of response on patient evolution).

    Biological best overall response - Only 16 assessable patients (Treatment arm only)

    *This measurement was only taken in participants from the treatment group as these present an active disease, therefore Rucaparib was administered in order to reduce tumoral charge or control tumor progression. On the other hand, participants from the maintenance group have already responded to previous treatments, and rucaparib was administered I order to maintain response rate and/or delay progression, which was measured using "free-progression survival".