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Conference News ESMO

The following articles are based on presentations at the 35th European Society for Medical Oncology Congress held in Milan, Italy, October 8-12, 2010.

For Breakthrough Cancer Pain, Fentanyl Nasal Spray Easily Titratable and Effective By Caroline Helwick

MILAN—Breakthrough pain in cancer patients can be managed easily and effectively with fentanyl pectin nasal spray (FPNS), according to new data. FPNS can be easily titrated to an effective dose and there is little need for rescue medication, according to David Brooks, MD, of Chesterfield and North Derbyshire Royal Hospital NHS Trust in Chesterfield, United Kingdom. “This study shows that if you put in the effort, you can titrate this drug to the right dose in the majority of patients, and they will stick with the treatment and achieve successful pain control,” Brooks said. The study’s first author was Luis Torres, MD, of the Servicio de Anestesia-Reanimacion y Tratamiento del Dolor, Hospital Puerta del Mar in Cadiz, Spain. Typically, breakthrough pain has a

rapid onset and is severe to excruciating in intensity, although the pain’s duration is relatively short, he said. Currently, immediate-release morphine is still the mainstay of treatment but takes at least 30 minutes for maximum effect. “Its onset is too slow for the appropriate management of breakthrough pain,” Brooks noted. Intranasal drug delivery is a simple and acceptable means of administering strong analgesics, and has rapid absorption, he said. Brooks reported on an analysis of the open-label dose-titration outcomes in the FPNS phase 3 clinical trial program involving 500 cancer patients with breakthrough pain. The program consisted of three studies, which found that there was rapid onset of efficacy and significant pain relief for FPNS versus placebo. The current analysis of

the program evaluated FPNS’s ease of titration, speed of relief, and reliability. Of the 500 patients, 401 (80.2%) were successfully titrated and continued through their treatments. Overall, they were successfully titrated to the following dosages: 100 µg (17.7%), 200 µg (12.8%), 400 µg (32.0%), and 800 µg (28.5%). FPNS required an average of only 2.7 steps for titration across the three studies, Brooks reported. Successful dose titration did not vary by age or weight. Success rates were consistent across the three multinational trials that involved 13 countries, the authors reported. Only 8% of patients could not be successfully titrated because of an FPNSrelated reason, most commonly an adverse event or inadequate efficacy at the highest dose. Treatment-related adverse events included headache, nau-

sea, and vomiting, which were consistent with the pharmacologic effects of fentanyl. Only 6% of FPNS-treated episodes required additional rescue medication within 60 minutes, and only 10% required an increase in dose for FPNS to maintain its efficacy. Of the 205 patients who completed the open-label treatment phase, 71% elected to continue treatment with FPNS in the ensuing extension period, Brooks noted. “I see this agent used not just for breakthrough pain but to preempt pain before it occurs, such as when patients get out of bed to go to the toilet,” he added. “As a preemptive analgesic it might allow for more activity.” This study was sponsored by Archimedes Pharma, which manufactures PecFent. ●

Sex and the Cancer Patient: Still a Problem with Targeted Agents MILAN—Sexual issues related to cancer and its treatment are substantial—and do not seem to be resolving with the use of new molecular targeted agents instead of endocrine therapy and chemotherapy. This conclusion can be drawn from two studies presented by investigators from Argentina and France. Argentine investigators questioned 29 female and 21 male cancer patients on issues of sexuality. Half were married and all had good performance status. Most of the women had gynecologic cancers (48% of the total population). Gastrointestinal cancers were seen in 30% overall and urologic cancers in 12%; the remainder were respiratory, head and neck, and skin cancers. “We found the three phases of human sexual response to be affected, all reaching statistical significance. Most impact was seen in females,” said Bonicatto Silvia, MD, of the Hospital San Roque de Gonnet in Buenos Aires. “When the descriptors of ‘a little’ versus ‘not at all’ were compared, the most affected areas were arousal and orgasm.” Although 84% of all patients reported “some” sexual arousal before treat-

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ment, this fell to 53% after treatment. Conversely, before treatment 16% reported “no arousal,” and this rose to 47% after treatment, Silvia reported. For orgasm, “some” orgasmic function was reported by 84% before treatment, declining to 53% after treatment, whereas “no” orgasms were reported by 16% and 47%, respectively. Desire was somewhat less affected, with 86% reporting desire at baseline and 69% posttreatment. Pre- and posttreatment means are shown in the Table. Women were particularly affected by a lack of lubrication. Before treatment, 64% reported lubrication or “vaginal wetness during sex,” but this dropped to 36% after treatment. For men, erectile dysfunction was less affected, with 52% reporting sexual function before treatment and 43% after treatment. Not surprisingly, sexual activity declined. Before their cancer treatments, 100% of men and 82% of women reported some degree of sexual activity. After treatment, 82% of men were still sexual but only 39% of women were.

Table

Desire Arousal Orgasm

Effect of Cancer Treatment on Key Sexual Areas (Scale 0-4) Before treatment (mean) 2.92 3.45 3.39

After treatment (mean) 2.47 2.31 2.61

Targeted agents affect sex life too Also at the meeting, French researchers reported on one of the few studies to investigate the impact of newer cancer treatments on sexual functioning, finding significantly decreased levels of sexual function and satisfaction in patients taking targeted therapies. Yohann Loriot, MD, and Thomas Bessede, MD, from the Institut Gustave Roussy in Villejuif, France, surveyed 51 patients (40 men, 11 women), median age 58, who had been treated with a targeted therapy for more than 3 months. The drugs involved were sunitinib, sorafenib, temsirolimus, everolimus, bevacizumab, erlotinib, and cetuximab. Men completed the International

Index of Erectile Function (IIEF) questionnaire and women completed the Female Sexual Function Index (FSFI) questionnaire. The median overall IIEF score for men was 40, which was just 53% of the maximum score (range, 5-75). Specifically, the mean scores (out of the maximum) were 14/30 for erectile function, 6/15 for intercourse satisfaction, 6/10 for orgasmic function, 6/10 for sexual desire, and 5/10 for overall satisfaction. Women scored even lower. Median FSFI was 8.4, which was just 24% of the maximum (range, 2-29.6). Mean scores were 2.2/6 for desire, 1.86/6 for arousal, 1.5/6 for lubrication, 1.7/6 for orgasm, 2.6/6 for satisfaction, and 2/6 for pain. “The sex lives of the patients in our study had reduced quality and intensity,” Loriot said. “We also found that more than half the patients expressed a wish for a satisfying sexual life, but many found it difficult to initiate a discussion on the topic with their doctors.” ● —CH Conference News continued on page 34

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