Persistent pain after surgery for cutaneous melanoma.

OBJECTIVES: Chronic pain is a well-known complication after surgery, but the prevalence of persistent pain after melanoma surgery is unknown. This study examined the prevalence and predictors of persistent pain after melanoma surgery. METHODS: Between September 2005 and June 2009, 448 patients underwent surgery for cutaneous melanoma at the Department of Plastic Surgery, Aalborg Hospital. A questionnaire was sent to all 402 survivors, and 350 (87.1%) responded. In addition, all patients with pain and a control group of sex-matched and age-matched patients without pain were invited to a clinical examination. RESULTS: Thirty-four patients (9.7%) reported pain in the scar area within the last month, and 8.6% reported chronic pain. The pain was mostly mild with little impact on daily life, but 1.7% reported moderate to severe pain, and 3.4% reported at least moderate impact of pain on daily life. Sensory changes were reported by 108 patients (31.5%); 25% of these had pain compared with 3% of patients with normal sensation [P<0.001, 10.8 (4.5 to 25.8)]. Young age was a predictor for persistent pain. A small group of patients (10 with and 22 without pain in the questionnaire) were clinically examined, suggesting that the areas of sensory disturbances were larger in patients reporting persistent pain or dysesthesia. DISCUSSION: The results support previous findings that persistent postoperative pain is a complication of almost any surgical intervention. Persistent pain was related to abnormal sensation, and neuropathic pain should be considered in these patients.

Persistent pain after lymph node excision in patients with malignant melanoma is neuropathic.

Persistent postoperative pain is a common complication of surgery, including surgical interventions for cancer. So far, there is limited information about the prevalence and clinical characteristics of pain after lymph node biopsy and dissection in patients with malignant melanoma. In this study, a questionnaire was sent out to all surviving patients (n=402) after surgery for cutaneous malignant melanoma at the Aalborg Hospital Department of Plastic Surgery, Aalborg, Denmark. Of patients responding, sentinel node biopsy (SNB) and/or lymph node dissection (LND) was performed in 175 patients. All patients with pain and a control group were invited to a clinical examination. Altered sensation and pain were significantly more common after LND (82% and 34%, respectively) than after SNB (32% and 14%, respectively). In patients with LND, 12% reported at least moderate pain and 14% impact of pain on quality of life, while in patients with SNB, 3% reported at least moderate pain and 2% pain impact on quality of life. The most important predictor of pain was sensory abnormalities. At the clinical follow-up, 10 out of 12 patients with pain both met the criteria of the recently proposed grading system for probable neuropathic pain and used descriptors on the DN4 questionnaire suggestive of neuropathic pain. Different patterns of sensory profiles were observed in single patients, suggesting heterogeneous sensory processing within single patients. This study suggested that nerve injury was the main underlying mechanism of persistent pain after lymph node excision.

Publication outcomes of phase II oncology clinical trials.

OBJECTIVES: Translation of evidence-based medicine into oncology practice depends on timely and full publication of clinical trials. We investigated publication outcomes of Phase II trial abstracts from the annual meetings of the American Society of Clinical Oncology (ASCO). METHODS: We searched the 1997, 1999, and 2001 ASCO annual meeting proceedings and identified all Phase II trials, excluding those that reported preliminary results. Literature search was performed using PubMed, EMBASE, and Google for corresponding publications in peer-reviewed journals. We attempted to contact authors of all unpublished trials. RESULTS: Only 60.8% of t he 559 trials identified were published, with a median time to publication of 41 months. At 5 years, 65.9%, 62.7%, and 57.0% of studies from 1997, 1999, and 2001, respectively, were published. Studies with larger samples were associated with a shorter time to publication, as were oral and poster presentations versus print only (P < 0.001). Common reasons for not publishing were uninteresting results, lack of time, and relocation of authors. Among abstracts reporting response rates, 37.7% showed different results in subsequent publications. Though not statistically significant, over the 5-year period, abstracts presented at later years had a lower rate of publication, longer time to publication, and a higher likelihood of showing a better tumor response. CONCLUSIONS: Almost half of Phase II trials presented at ASCO annual meetings within the last 10 years remain unpublished. Over one-third of published trials reported results different from those presented in abstracts. Like Phase I and III trials, Phase II trials often are unpublished.