BACKGROUND. Few studies have examined the costs of supportive care for radiochemotherapy-induced mucosits/pharyngitis among patients with head and neck cancer (HNC) or lung cancers despite the documented negative clinical impact of these complications. METHODS.The authors identified a retrospective cohort of patients with HNC or nonsmall lung cancer (NSCLC) who had received radiochemotherapy at 1 of 3 Chicago hospitals (a Veterans Administration hospital, a county hospital, or a tertiary care hospital). Charts were reviewed for the presence/absence of severe mucositis/pharyngitis and the medical resources that were used. Resource estimates were converted into cost units obtained from standard sources (hospital bills, Medicare physician fee schedule, Red Book). Estimates of resources used and direct medical costs were compared for patients who did and patients who did not develop severe mucositis/pharyngitis. RESULTS.Severe mucositis/pharyngitis occurred in 70.1% of 99 patients with HNC and in 37.5% of 40 patients with NSCLC during radiochemotherapy. The total median medical costs per patient were $39,313 for patients with mucositis/ pharyngitis and $20,798 for patients without mucositis/pharyngitis (P 5 .007).Extended inpatient hospitalization accounted for $12,600 of the increased medical costs (median 14 days [$19,600] with severe mucositis/pharyngitis vs 5 days [$7000] without; P 5 .017). For patients who had HNC with mucositis/pharyngitis, incremental inpatient hospitalization costs were $14,000, and total medical costs were $17,244. For patients who had NSCLC with mucositis/pharyngitis, these costs were $11,200 and $25,000, respectively.CONCLUSIONS. In the current study, the medical costs among the patients with HNC and NSCLC who received radiochemotherapy were greater for those who developed severe mucositis/pharyngitis than for those who did not. Cancer
An intervention based on mailing a customized brochure to patients who were referred for a screening colonoscopy improved CRC screening rates at a university-based general medicine clinic. This intervention was comparable in effectiveness and cost-effectiveness to a similar recently reported low-intensity patient-directed CRC screening intervention, and markedly more affordable and cost-effective than a previously reported physician-directed CRC screening promotion intervention.
Background: At ASH 2005, we reported that 9 drugs had received accelerated approval (AA) for 11 hematologic indications since 1992, and that only 2 of these drugs had fulfilled post-marketing requirements for conversion to regular approval. Following our original report in 2004, only 1 drug had converted to regular approval by 2005. At that time, we suggested that the FDA establish stricter post-marketing milestones, a suggestion echoed in Congressman Ed Markey’s report “Conspiracy of Silence.” Two years later, we update the experience with AA for hematologic indications and reevaluate the FDA’s post-marketing approval process. Methods: Information on approval status and the clinical trials which form the basis of AA was obtained from the FDA website, product inserts, and medical literature reviews. Results: Since 1992, 11 drugs have received AA for 14 hematologic indications. Post-marketing requirements have been fulfilled for only 2 indications (14%), and none have converted to regular approval since 2005. The median time since AA for the 12 indications with pending post-marketing commitments is 5.5 years. For solid tumors and supportive oncology, by contrast, 15 drugs have received AA for 15 indications; Subpart H requirements have been fulfilled for 9 indications (56%). The median time to completion of post-marketing commitments for oncologic and supportive indications is 8 years, and the median time since AA for indications with pending commitments is 3 years. The mean number of patients in clinical trials for AA is 155 for hematologic indications and 1567 for solid tumor and supportive indications. Conclusions: The rate of conversion to regular approval for drugs with hematologic indications remains low. Our prior recommendation for stricter post-marketing milestones seems to be an untenable solution given the stagnancy of the approval process since our last report. Completion of Subpart H commitments may simply be unachievable, due to small numbers of patients and slow accrual to clinical trials following AA, in part due to violation of equipoise. We therefore revise our approach to AA. Surrogate endpoints are typically predictive of clinical benefit, while safety signals are often missed in early trials; the FDA should concentrate on preventing harm by mandating drug companies to keep safety registries after AA is granted, while still encouraging the emergence of new drugs for rare diseases through AA. Drug AA Indication/Date Years since AA # pts in trials on which AA based Date Subpart H commitment fulfilled (P=Pending) BORTEZOMIB MYELOMA-5/13/03 4.25 193 3/25/05 IMATINIB CML, INITIAL TX-5/10/01 6.25 864 12/8/03 Nelarabine T Cell ALL-10/28/05 1.8 68 P Clofarabine Pediatric ALL-12/28/04 3.33 74 P Tositumomab Rituxan-naive follicular NHL (expanded indication)-12/22/04 3.33 130 P Tositumomab Rituxan-refractory NHL-6/27/03 4.1 100 P Imatinib Pediatric CML-5/20/03 4.25 39 P Imatinib GIST-2/1/02 5.5 147 P Ibritumomab NHL-2/19/02 5.5 157 P Alemtuzumab CLL-5/7/01 6.25 93 P Gemtuzumab CD33+ AML-5/17/00 7.25 42 P Cytarabine liposomal Lymphomatous meningitis-4/1/99 8.33 14 P Denileukin Diftitox Cutaneous T cell lymphoma-2/5/99 8.5 71 P Doxorubicin liposomal AIDS-related Kaposi’s sarcoma-11/17/95 11.75 77 P AA for Hematologic Indications Drug AA Indication/Date Years since AA # pts in trials on which AA based Date Subpart H commitment fulfilled (P=Pending) BORTEZOMIB MYELOMA-5/13/03 4.25 193 3/25/05 IMATINIB CML, INITIAL TX-5/10/01 6.25 864 12/8/03 Nelarabine T Cell ALL-10/28/05 1.8 68 P Clofarabine Pediatric ALL-12/28/04 3.33 74 P Tositumomab Rituxan-naive follicular NHL (expanded indication)-12/22/04 3.33 130 P Tositumomab Rituxan-refractory NHL-6/27/03 4.1 100 P Imatinib Pediatric CML-5/20/03 4.25 39 P Imatinib GIST-2/1/02 5.5 147 P Ibritumomab NHL-2/19/02 5.5 157 P Alemtuzumab CLL-5/7/01 6.25 93 P Gemtuzumab CD33+ AML-5/17/00 7.25 42 P Cytarabine liposomal Lymphomatous meningitis-4/1/99 8.33 14 P Denileukin Diftitox Cutaneous T cell lymphoma-2/5/99 8.5 71 P Doxorubicin liposomal AIDS-related Kaposi’s sarcoma-11/17/95 11.75 77 P
5131 Background: HT may lower PSA, but it may also cause hot flashes and sexual dysfunction. OBS is not associated with hot flashes or lower testosterone production, but PSA may rise. Examining patient satisfaction with treatment decision making, treatment choice, and HRQOL may help improve disease management. We compared treatment satisfaction and HRQOL of patients who chose OBS over HT. Methods: The Comprehensive Multicenter Prostate Adenocarcinoma Registry (COMPARE) is an observational registry of men with PSA failure. Data from patient-reported questionnaires were analyzed for patients treated with OBS or HT. Results: 674 patients (82%) chose OBS; 147 (18%) chose HT. The median time between cancer diagnosis and registry enrollment was 6 years. Of men on OBS, 85%, 83%, and 71% were satisfied with treatment decision process, treatment choice, and treatment outcome, respectively. Men on HT had similar rates of satisfaction (82%, 75%, and 71%). Men initially treated with brachytherapy/surgery were less satisfied with OBS. Men initially treated with external beam radiation were less satisfied with HT. Patients reported similar problems with urinary, sexual, and bowel function. Conclusions: Men with PSA failure seem content with treatment choice and decision making and have low rates of urinary/bowel problems. Rates of sexual dysfunction in both groups are similar. Clinical trials may help determine if HT improves long-term outcomes (e.g. overall survival), since short-term patient reported satisfaction is similar between OBS and HT. The reported rate of sexual dysfunction is lower than expected. [Table: see text] [Table: see text]
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