18F-FPPRGD2 PET/CT or PET/MRI in Predicting Early Response in Patients With Cancer Receiving Anti-Angiogenesis Therapy

Maximum standard uptake values (SUVmax) were assessed on the basis of position emission tomography (PET) scans using radiotracers 18F-FPPRGD2 and 18F-FDG at baseline and at regular medical care follow-up (6 to 12 weeks after initiation of treatment). The outcome is assessed as the difference in the maximum standard uptake values (SUVmax) values from baseline to follow-up for the 2 radiotracers, and will be reported for each disease type as the median with standard deviation.

Time frame: At baseline and 6 weeks

Population: Some participants did not contribute some or all post-treatment scans.

The treatment effect for participants with gynecological cancers (GYN) and renal cell carcinoma (RCC) was assessed on the basis of change in tumor size as determined by pre- and post-treatment CT scans. The outcome is reported as the difference at treatment follow-up, reported as the median with standard deviation.

Time frame: 9 to 12 weeks

Population: This assessment was restricted to gynecological cancers and renal cell carcinoma participants only. Tumor response data was not available for all participants in these groups.

Progression-free survival (PFS) was defined as remaining alive at 1 year with disease progression, according to the physician's assessment of clinical status, by disease group.

Time frame: 1 year

Population: Data was not collected for progression-free survival (PFS).

The treatment effect for participants with glioblastoma multiforme was to be assessed on the basis of post-treatment evaluation per the Response Assessment in Neuro-Oncology (RANO) Criteria. The outcome was the number & proportion of participants that achieved either a complete response (CR) or partial response (PR), a number without dispersion. RANO criteria are: CR= No T1 gadolinium (T1-G); T2-weighted-Fluid-Attenuated Inversion Recovery (T2/FLAIR) stable/decreased, no new lesions; no corticosteroids; clinical condition improved/stable. PR= ≥50% decrease in T1-G; T2/FLAIR decreased/stable ; no new lesions; decreased/stable corticosteroids; clinical condition improved/stable. Stable disease (SD)= \<50% decrease, but more than 25% increase, in T1-G; T2/FLAIR decreased/stable; no new lesions; decreased/stable corticosteroids; clinical condition improved/stable. Progressive disease (PD)= ≥25%increase T1-G; T2/FLAIR increased; increased corticosteroids; clinical condition decreased

Time frame: At baseline and 6 weeks

Population: This assessment was restricted to glioblastoma multiforme (GBM) participants only, however, no response assessments were obtained for GBM participants.

Tumor Response Rate by EORTC Criteria Tumor response rates were assessed from position emission tomography (PET) scans using 18F-FPPRGD2 & 18F-FDG at baseline & after 6 weeks of treatment, per European Organization for Research & Treatment of Cancer (EORTC) response criteria. The outcome is reported for each radiotracer by disease group as the number of participants achieving complete response (CR), partial response (PR), stable disease (SD), & progressive disease (PD). * CR= complete resolution of 18F-FDG uptake tumor volume * PR= reduction of 15-25% in tumor 18F-FDG SUVmax after 1 cycle of chemotherapy, and ≥25% after \>1 cycle * SD= increase in tumor 18F-FDG SUVmax of \<25% or a decrease of \<15% & no increase in 18F-FDG tumor uptake \[\>20% in the longest dimension (LD)\]; * PD= increase in 18F-FDG tumor SUVmax of \>25% in tumor region on baseline; increase in extent of 18F-FDG tumor uptake (\>20% in LD); appearance of new 18F-FDG uptake in metastatic lesions

Time frame: At baseline and 6 weeks

Population: This assessment was restricted to gynecological cancers and renal cell carcinoma participants only. Tumor response data was not available for all participants in these groups.