Carboplatin and pegylated liposomal doxorubicin versus carboplatin and paclitaxel in partially platinum-sensitive ovarian cancer patients: results from a subset analysis of the CALYPSO phase III trial.

BACKGROUND: To perform a subset analysis of patients with partially platinum-sensitive recurrent ovarian cancer (ROC) who received either CD [carboplatin-pegylated liposomal doxorubicin (PLD)] or CP (carboplatin-paclitaxel) in the CALYPSO trial. PATIENTS AND METHODS: CALYPSO, an international phase III, non-inferiority trial, enrolled women with ROC that relapsed >6 months following first- or second-line therapy. Patients were randomized to CD or CP. Patients with a treatment-free interval of >6 and ≤ 12 months were evaluated for progression-free survival (PFS), the primary end point of CALYPSO trial, and safety. RESULTS: A total of 344 partially platinum-sensitive patients were included (N = 161, CD and N = 183, CP). The hazard ratio for PFS was 0.73 (95% confidence interval: 0.58-0.90; P = 0.004 for superiority) in favor of CD. Median PFS times were 9.4 months (CD) and 8.8 months (CP). Toxicities more common with CP versus CD included grade 3/4 neutropenia (50% versus 39%; P = 0.015), grade 2 alopecia (86% versus 9%; P < 0.001), neuropathy and hypersensitivity reactions. Hand-foot syndrome was more common with CD; however, grade 3/4 reactions were low (one patient in each arm). CONCLUSION: Carboplatin-PLD has a more favorable risk-benefit profile than CP in patients with partially platinum-sensitive ROC and should be considered an effective treatment option for these patients.

Early pregnancy termination with mifepristone and misoprostol in Norway.

OBJECTIVES: Medical abortion was first introduced in Norway in April 1998. The aims of this study were to assess the efficacy, side effects, and acceptability of medical abortion using mifepristone orally and misoprostol vaginally in a Norwegian population. DESIGN: The study included the first 226 pregnant women with gestational age of <63 days who requested nonsurgical abortion during the first year in the first Norwegian hospital using this regimen. METHODS: All women received a single dose of mifepristone 600 mg orally, followed at 48 hours by 800 microg misoprostol vaginally. Treatment outcome and complications were the principal outcome measures. We also measured the rates of side effects such as abdominal pain and bleeding and the women's acceptability of treatment. RESULTS: Abortion was successful in 95%, surgical evacuation became necessary in 4%, and the pregnancy continued in one woman. During the study period the method was chosen by 23% of those requesting abortion before 63 days amenorrhea; 80% would use the method again; 81% would recommend it to a friend; in retrospect, 69% would not have been willing to be randomly allocated to either a medical or a surgical method. CONCLUSIONS: The combination of orally administrated mifepristone and vaginally administrated misoprostol is an abortion method that is both effective and safe, has few side effects and is well accepted by Norwegian women.

The general health in women suffering from gynaecological disorders is improved by means of hysterectomy.

Gynaecological disorders can have adverse effects on women's general health, and for a substantial number of these women hysterectomy is performed. This study aims to evaluate the long-term impact of hysterectomy on this outcome variable. The patient-group was tested pre-operatively and 6 and 12 months after hysterectomy. The control-group was tested once. This study shows that the general health in women suffering from gynaecological disorders is significantly lower compared with that of the control-group (p < 0.00). Both 6 and 12 months after the hysterectomy, however, the patient-group has reached the same level of their general health as the control-group. Twenty-eight per cent of their potentiality for improved health has been obtained. For those women with poorest health both pre- and postoperatively, other factors than the hysterectomy have had a negative impact on their general health and lives. The results from this study suggest that hysterectomy is associated with a positive long-term impact on women's general health.

Are the physiologically and psychosocially based symptoms in women suffering from gynecological disorders alleviated by means of hysterectomy?

Women experiencing gynecological disorders can suffer from a diversity of symptoms and problems. To what extent women are relieved of their physiologically and psychosocially based symptoms by hysterectomy is an important issue. This study aims to evaluate the long-term impact of hysterectomy on such symptoms and to compare the findings with those of a control group. Women with gynecological disorders experienced physiologically based symptoms, such as pelvic pain and urinary incontinence, to a greater degree than did the control group (p < 0.05), whereas bowel function and menopausal symptoms were equally distributed in the two groups. Furthermore, these women experienced psychosocially based symptoms, such as fatigue and insomnia, to a greater degree than the control group (p < 0.05), whereas the groups did not differ in psychological well-being or sexual function. After hysterectomy, however, pelvic pain and sleeping disturbances were alleviated, and the state of energy and urinary function were improved (p < 0.00). Bowel function, menopausal symptoms, psychological well-being, sexual function, and self-perception as a woman were not influenced by the operation. Both 6 and 12 months after hysterectomy, no differences between the patients and the control group were found, except for the tendency of patients not to gain weight after the operation. The symptoms are mostly improved or unchanged after hysterectomy, and additional problems do not seem to follow the operation.

The quality of life in women suffering from gynecological disorders is improved by means of hysterectomy. Absolute and relative differences between pre- and postoperative measures.

BACKGROUND: Gynecological disorders can have adverse effects on a woman's quality of life. Most hysterectomies are thus performed to enhance women's quality of life rather than to save life. This study aims at evaluating the long-term impact of hysterectomy on this outcome variable. METHODS: The quality of life in 111 women undergoing hysterectomy for benign reasons was tested before, and six and twelve months after, the operation. A control-group of non-hysterectomized women from the normal population was tested once. Ferrans & Powers' Quality of Life Index, consisting of four life domains, was used. This index has a pre-set highest possible obtainable score. For the subjects with a high pre-test score, there was little scope for further measurable improvement after hysterectomy, which gives a false stability in the material. A method for calculating the relative differences was introduced. RESULTS: The health and functioning domain of the quality of life among women awaiting hysterectomy is significantly lower compared to that of the control-group (p<.01) Both six and twelve months after the hysterectomy, the patients have reached the same level of their health and functioning as the control-group. Using the relative difference-form, it is demonstrated that the subjects have obtained significantly higher levels in all the domains of quality of life after hysterectomy. CONCLUSIONS: The results of this study show that hysterectomy is associated with a positive long-term impact on a woman's quality of life.

Quality of life, pain, and psychological well-being in women suffering from gynecological disorders.

Most gynecological disorders are not life threatening. They may nevertheless severely affect women's lives. This study was conducted to investigate quality of life (QOL), pain, and psychological well-being in women suffering from such disorders compared with a control group. Women with benign gynecological disorders who are awaiting hysterectomy have a lower score in the health and functioning domain of QOL compared with the control group. More than three of four patients experience pain, mostly pelvic pain. Pain has a clear negative influence on women's QOL, pelvic pain to a greater degree than other types of pain. The patients report the same degree of psychological well-being as the control group. Benign gynecological disorders have a clear negative impact on women's health and functioning, and pain is a major problem for these patients. The more pain, the lower QOL. Their psychological well-being, however, does not seem to be affected.