Statement: As the primary trial and the secondary trial use very similar outcome metrics, we can easily compare and contrast across their results.
Primary_evidence: Outcome Measurement:    Level of EGFR Expression   Estimated at the end of the trial Immunoreactivity will be evaluated qualitatively with regard to intensity as follows: Measured on a scale, ranging from 0-3+ 0=negative (no immunoreactivity) 1+ - 3+ = positive:   faint immunoreactivity (weak staining)   intense immunoreactivity (strong staining) Immunohistochemical studies will be performed on the tumor specimen to correlate the anti-tumor efficacy of OSI-774 and bevacizumab with pre-treatment molecular characteristics.   Time frame: Up to 12 years Results 1:    Arm/Group Title: Treatment (Erlotinib Hydrochloride, Bevacizumab)   Arm/Group Description: Patients receive erlotinib hydrochloride PO QD on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.   Overall Number of Participants Analyzed: 38   Measure Type: Number   Unit of Measure: participants  EGFR 0: 24 EGFR 1+: 8 EGFR 2+: 4   EGFR 3+: 0   Insufficient tumor tissue: 2
Secondary_evidence: Outcome Measurement:    Systemic Tumor Response Rates (Complete Response+Partial Response)   The systemic tumor response refers to the response at the time of best overall response. The response criteria are specially adapted from Response Evaluation Criteria in Solid Tumor for Immunotherapies (Wolchok, et al., 2009).   Time frame: 9 weeks from the start of the treatment of RT Results 1:    Arm/Group Title: IMQ+RT   Arm/Group Description: This arm has been closed as of 6/4/2014.   Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)   Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied to all skin sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period.   Week 9: response assessment   Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.   Radiation   Imiquimod   Overall Number of Participants Analyzed: 12   Measure Type: Number   Unit of Measure: proportion of tumors  .25        (.06 to .57) Results 2:    Arm/Group Title: CTX/IMQ/RT   Arm/Group Description: Week -1 (day-7): cyclophosphamide 200mg/m2 IV as single infusion   Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)   Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied all sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period.   Week 9: response assessment   Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.   Radiation   Imiquimod   Cyclophosphamide   Overall Number of Participants Analyzed: 12   Measure Type: Number   Unit of Measure: proportion of tumors  .083        (.002 to .38)