BACKGROUND Incidence of cutaneous melanoma continues to increase in the Caucasian population worldwide. Approximately 5% of melanoma patients develop additional primary melanoma. This rate is significantly higher than the estimated lifetime risk of an individual for developing the disease (1.4%). These features suggest that a genetic predisposition may underlie multiple primary melanomas (MPMs). Prior studies had identified CDKN2A mutations in a few MPM individuals. The objectives of this study were to determine the frequency of family history of melanoma in MPM cases, to characterize other clinical features including history of other cancer, and to determine the association with functional CDKN2A mutations. METHODS This study used a case series design. All living patients who had been seen in the Pigmented Lesion Clinic at the University of Pennsylvania and who had more than one primary invasive malignant melanoma or an invasive primary followed by an in situ melanoma were eligible for participation. RESULTS Individuals with MPM frequently had a family history of melanoma, dysplastic nevi (DN), and/or another cancer including basal cell carcinoma (BCC), and squamous cell carcinoma breast cancer, and a personal history of DN, and basal cell carcinoma. Germline mutations in CDKN2A gene were identified in 8 of 96 MPM cases (8.3%, 95% confidence interval, 6.7–9.9%). CONCLUSIONS These data indicate that the presence of MPM is associated with a modest incidence of a family history of melanoma, DN, or BCC and a small association with CDKN2A mutations. Therefore, in addition to the MPM index case, other family members can benefit from screening and regular surveillance for melanoma, DN, and BCC. Cancer 2002;94:2248–55. © 2002 American Cancer Society. DOI 10.1002/cncr.10454
were included. FDA designation, approval date and pivotal trial data were acquired from the Drugs@FDA index. Results: For 29 of 31 drug/indication combinations investigated, those launched second or later were approved with trial data equal to or more mature (superior endpoint or later trial phase) than first drugs to market. Early trial data (Phase I or II) and immature endpoints (objective response rate) were more likely to be submitted for launches in indications with a higher unmet need. Indications with a 5-year survival rate , 20% were more likely to submit immature data (9/15, 60%) than indications with a 5-year survival rate .20% (6/13, 46%), (one drug was excluded from analysis). Phase I data were only submitted for first-tomarket drugs (N=2) with 5-year survival rates of ,20%. Conclusions: In this sample, 9/15 oncology products launched in indications with low (,20%) 5-year survival were approved with immature data for FDA approval compared to 6/13 in indications with 5-year survival rates .20%. This has implications for strategies by pharmaceutical companies in terms of evidence generation and launch sequencing in the US market and the resulting access to oncology drugs for high unmet needs.
17064 Background: The National Comprehensive Cancer Network (NCCN) provides yearly updated guidelines for the management of patients diagnosed with small cell lung cancer (SCLC). Compliance to clinical guidelines may improve patient care and outcome, but this may vary among institutions. In this study, we determined the compliance of our community cancer center to the NCCN guidelines in patients with SCLC. Methods: We identified patients with newly diagnosed SCLC in 2004 and 2005 using our cancer registry database. Using the NCCN guideline for the corresponding years, we determined the compliance rate for the following phases of cancer care: initial evaluation (pathology review, imaging, smoking cessation counseling, mediastinal staging for T1-T2 limited disease), and treatment (chemotherapy, radiation). Results: There were 39 new patients with SCLC, 14 (35.9%) of which had limited stage disease. The overall compliance rates for initial evaluation and treatment were 33.3%, and 92.3%, respectively. A total of 32 deviations were identified: 21 (65.6%) for neglecting smoking cessation counseling, 7 (21.9%) for not performing recommended imaging, 3 (9.4%) for not giving recommended chemotherapy and/or radiation and 1 (3.1%) for not reviewing outside pathology. In all of the imaging and treatment deviations, there were medically appropriate reasons for doing so: 7 patients with limited disease had PET/CT scan instead of CT/bone scan (PET/CT scan now incorporated into the 2006 guidelines); 2 patients with limited disease did not receive concurrent chemoradiotherapy due to poor performance status and co-morbidity; 1 patient with extensive disease refused chemotherapy. Conclusion: Our compliance with NCCN guidelines for SCLC was poor for initial evaluation, but better for treatment. The primary reasons for this outcome were the lack of a perceived benefit in smoking cessation counseling and the use of PET/CT scanning as the initial imaging modality of choice. No significant financial relationships to disclose.
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