Assessment of Efficacy of AZD2281 in Platinum Sensitive Relapsed Serous Ovarian Cancer

PFS was defined as the time from randomisation to the earlier date of radiological progression (per RECIST criteria) or death by any cause in the absence of objective progression. \[Full analysis set (FAS)\]

Time frame: Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.

Best overall response from radiologic assessments. \[FAS\]

Time frame: Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter, assessed maximum up to 14 months.

Best percentage change from baseline in CA-125 level

Time frame: CA-125 was measured at baseline then every 28 days on treatment, assessed maximum up to 14 months.

Population: A subset of the FAS with baseline and at least 1 follow-up value of CA-125

Disease control rate was defined as the percentage of patients who have at least 1 confirmed visit response of CR or PR or have demonstrated SD or NED for at least 23 weeks (ie, 24 weeks +/- 1 week) prior to any evidence of progression. \[FAS\]

Time frame: Assessed at 24 weeks. Radiologic scans performed at baseline, week 12 (+/- 1 week) and week 24 (+/- 1 week).

Duration of response = time from assessment prior to timepoint where PR or CR confirmed (i.e. initial assessment of PR/CR), until earliest date of objective progression or death. \[Responding patients only\]. There were insufficient responses to enable conclusions to be drawn.

Time frame: Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.

The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. \[Evaluable for FOSI set\]

Time frame: Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.

The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. \[Evaluable for FACT-O set\]

Time frame: Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.

The percentage of patients with an improvement in FOSI. Improvement was defined as a change from baseline of greater than or equal to +3. \[Evaluable for FOSI set\]

Time frame: Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.

Population: Evaluable for FOSI set - A subset of the full analysis set which includes patients who have evaluable QoL/Symptom Endpoints at baseline

The percentage of patients with an improvement in total FACT-O. Improvement was defined as a change from baseline of greater than or equal to +9. \[Evaluable for FACT-O set\]

Time frame: Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.

Population: Evaluable for Total Fact-O set - A subset of the full analysis set which includes patients who have evaluable QoL/Symptom Endpoints at baseline

The percentage of patients with an improvement in TOI. Improvement was defined as a change from baseline of greater than or equal to +7. \[Evaluable for TOI set\]

Time frame: Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.

Population: Evaluable for TOI - a subset of the full analysis set which includes patients who have evaluable QoL/Symptom Endpoints at baseline

For each treatment group, the ORR was the number of Complete Response (CR) and Partial Response (PR) divided by the number of patients in the group in the FAS with measurable disease at baseline (displayed as a percentage below). Evaluable for response set

Time frame: Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.

Population: Evaluable for response set - A subset of the full analysis set which includes patients with measurable disease at baseline

OS = time from randomisation to date of death from any cause. Patients who had not died at time of analysis were censored at last date patient was known to be alive.

Time frame: Follow up every 12 weeks post progression, assessed maximum up to 90 months.

Percentage change from baseline to Week 24 in target tumour size.

Time frame: Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.

Population: Evaluable for response set - A subset of the full analysis set which includes patients with measurable disease at baseline.

RECIST and CA-125 response separately and combined \[Patients evaluable for either CA-125 response or RECIST response\]

Time frame: Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter and monthly for CA-125 measurements, assessed maximum up to 14 months.

Time from randomisation to the earlier date of radiological progression (per RECIST criteria) or CA-125 or death by any cause in the absence of objective progression. \[FAS\]

Time frame: Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter and monthly for CA-125 measurements, assessed maximum up to 14 months.

The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. \[Evaluable for TOI set\]

Time frame: Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.