BACKGROUND Limited knowledge exists concerning the impact of radical hysterectomy (RH) alone on the sexual function of patients with early‐stage cervical carcinoma. The authors investigated the longitudinal course of self‐reported sexual function after RH. METHODS The current study was comprised of 173 patients with lymph node‐negative, early‐stage cervical carcinoma who had undergone RH and pelvic lymphadenectomy. They were assessed prospectively using a validated self‐assessment questionnaire 5 weeks and 3 months, 6 months, 12 months, 18 months, and 24 months after RH. Results were compared with an age‐matched control group from the general population. RESULTS Compared with control women, patients experienced severe orgasmic problems and uncomfortable sexual intercourse due to a reduced vaginal size during the first 6 months after RH, severe dyspareunia during the first 3 months, and sexual dissatisfaction during the 5 weeks after RH. A persistent lack of sexual interest and lubrication were reported throughout the first 2 years after RH. Long‐term lack of sexual interest and insufficient vaginal lubrication were confirmed by the patient's self‐reported changes 12 months after RH compared with before the cancer diagnosis and by a pre‐post comparison within patients. However, most of the patients who were sexually active before their cancer diagnosis were sexually active again 12 months after surgery (91%), although with a decrease in sexual frequency reported. CONCLUSIONS RH had a persistent and negative impact on patients' sexual interest and vaginal lubrication whereas the majority of other sexual and vaginal problems disappeared over time. Sexual and vaginal problems in the short‐term and long‐term after RH should be discussed with the patient before and after surgery. Cancer 2004;100:97–106. © 2003 American Cancer Society.

BACKGROUNDThe authors report on the development and validation of a cervical cancer module for the European Organization for Research and Treatment of Cancer (EORTC) Quality‐of‐Life (QoL) questionnaire (QLQ), which was designed to assess disease‐specific and treatment‐specific aspects of QoL in patients with cervical cancer.METHODSThe cervical cancer module (EORTC QLQ‐CX24) was developed in a multicultural, multidisciplinary setting to supplement the EORTC QLQ‐C30 core questionnaire. The QLQ‐C30 and the cervical cancer module were administered to 346 patients with cervical cancer who underwent radical hysterectomy and received radiotherapy and chemotherapy. Psychometric analyses were performed by using data from 2 independent samples.RESULTSThe QLQ‐CX24 consists of 3 multiitem scales and 5 single‐item scales. Multitrait scaling analyses revealed high internal consistencies for the subscales with Cronbach α coefficients ranging from .72 to .87 (Symptom Experience, .72; Body Image, .86; Sexual/Vaginal Functioning, .87). Convergent and discriminant validity were fulfilled with scaling errors below 3%. The QLQ‐CX24 was capable of discriminating between clinical subgroups. All items exhibited good compliance with <3% missing values. Most patients completed the EORTC QLQ‐C30 and the QLQ‐CX24 in <15 minutes (86%), and many did not require any assistance to complete the questionnaires (65%).CONCLUSIONSThe current psychometric analyses supported the content and construct validity and the reliability of the EORTC QLQ‐CX24 module. This newly developed module is a useful instrument for assessing the QoL of patients who are treated for cervical cancer both in clinical trials and in clinical practice. Cancer 2006. © 2006 American Cancer Society.

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5501 Background: The role of secondary cytoreductive surgery in recurrent ovarian cancer (OC) has not been defined by level-1 evidence. Methods: Pts with OC and 1st relapse after 6+ mos platin-free interval (TFIp) were eligible if they presented with a positive AGO-score (PS ECOG 0, ascites ≤500 ml, and complete resection at initial surgery) and were randomized to 2nd-line chemotherapy alone vs cytoreductive surgery followed by chemo. Chemo regimens were selected according to the institutional standard. We report here results of the predetermined interim analysis. Results: 407pts were randomized 2010-2014. The TFIp exceeded 12 mos in 75% and 76% pts in both arms. 8.9% of 203 pts were operated despite of randomization to the no-surgery arm, whereas 6.9% of 204 pts in the surgery arm did not undergo operation. Complete resection was achieved in 67% of pts; 87% and 88% received a platinum-containing 2nd-line therapy. Median PFS was 14 mos without and 19.6 mos with surgery (HR: 0.66, 95%CI 0.52-0.83, p<0.001). Median time to start of first subsequent therapy (TFST) was 21 vs 13.9 mos in favor of the surgery arm (HR 0.61, 95%CI 0.48-0.77, p=p<0.001). PFS-2 between 1st and 2nd relapse equaled or even exceeded PFS-1 before 1strelapse in 26% after surgery and only 16% without-surgery. Analysis of the primary endpoint OS is kept blinded due to immaturity and will be evaluated after extended follow-up (the observed pooled unblinded 2-YSR was 83% instead of the initially in the protocol assumed 55-66%). 60d mortality rates were 0 and 0.5% in the surgery and no-surgery arm. Re-laparatomies were performed in 7 pts (3.5%) in the surgery arm.With the exception of myelosuppression which occurred more frequently in the no-surgery arm no further significant differences were observed with respect to grade 3+ acute adverse events. Conclusions: Surgery in pts with 1st relapse of OC after a TFIp of 6+ mos and selected by a positive AGO-Score resulted in a clinically meaningful increase of PFS and TFST with acceptable treatment burden. Until final OS data will definitively define the role of secondary cytoreductive surgery it should at least be considered as valuable option in pts with a positive AGO-Score. Clinical trial information: NCT01166737.

BACKGROUNDResearch in palliative care is considered difficult due to the poor health of patients. However, patient‐provided data are essential for a thorough description of patient symptomatology and for the evaluation of care.METHODSThe authors examined the feasibility of a questionnaire‐based study using the European Organization for Research and Treatment of Cancer quality‐of‐life instrument EORTC QLQ‐C30, the Edmonton Symptom Assessment System (ESAS), and the Hospital Anxiety and Depression Scale (HADS) in cancer patients who were receiving palliative care. This report describes the symptomatology of participating patients and examines differences in symptomatology between patients in three palliative care functions: inpatient, outpatient, and palliative home care.RESULTSOf 267 eligible patients who were referred to a department of palliative medicine, initial self‐assessment questionnaires were obtained from 176 patients (65.9%). The 91 nonparticipants were older and had lower Karnofsky Performance status (KPS) values than the participants. Almost all participating patients suffered from impaired role function and physical function and had high levels of pain, fatigue, and other symptoms. According to the HADS, 47% of patients suffered from depression. Outpatients had better scores than inpatients and patients in palliative home care for physical function, role function, cognitive function, depression, and inactivity.CONCLUSIONSIt is possible to carry out a questionnaire‐based study of symptomatology in consecutive cancer patients in palliative care, achieving rather complete data from the participants. The symptomatology in these patients was very pronounced. The questionnaires were able to detect clinically important differences between places of service. Cancer 2002;94:512–20. © 2002 American Cancer Society.

6000 Background: The role of secondary cytoreductive surgery in recurrent ovarian cancer (ROC) has been under debate for decades. A recent trial in unselected patients (pts) failed to show an OS benefit. Methods: Pts with ROC and 1st relapse after 6+ months (mos) platinum-free interval (TFIp) were eligible if they presented with a positive AGO-score (PS ECOG 0, ascites ≤500 ml, and complete resection at initial surgery) and were prospectively randomized to second-line chemotherapy alone vs. cytoreductive surgery followed by the same chemotherapy; platinum combination therapy was recommended. OS was primary endpoint in this superiority trial. Results: 407pts were randomized 2010-2014. The TFIp exceeded 12 mos in 75% of pts. 206 pts were allocated to the surgery arm of whom finally 187 (91%) were operated. A complete resection was achieved in 75%; almost 90% in both arms received a platinum-containing second-line chemo. Primary endpoint analysis showed median OS of 53.7 mos with and 46.2 mos without surgery (HR 0.76, 95%CI 0.59-0.97, p=0.03); median PFS was 18.4 and 14 mos (HR: 0.66, 95%CI 0.54-0.82, p<0.001), median time to start of first subsequent therapy (TFST) was 17.9 vs. 13.7 mos in favor of the surgery arm (HR 0.65, 95%CI 0.52-0.81, p<0.001). An analysis according to treatment showed an OS benefit exceeding 12 mos for pts with complete resection (CR) compared to pts without surgery (median 60.7 vs. 46.2 mos); pts with surgery and incomplete resection even did worse (median 28.8 mos). 60 d mortality rates were 0 and 0.5% in the surgery and no-surgery arm. Re-laparotomies were performed in 3.7% of operated pts. Further grade 3/4 adverse events did not differ significantly between arms. Conclusions: This is the first surgical study demonstrating a meaningful survival benefit in OC: Surgery in pts with first relapse and TFIp of 6+ mos and selected by a positive AGO-Score resulted in a significant increase of OS, PFS and TFST with acceptable morbidity and, therefore, should be offered to suitable pts. The benefit was exclusively seen in pts with CR indicating the importance of both the optimal selection of pts (eg. by AGO score) and of centres with expertise and a high chance of achieving a CR. Clinical trial information: NCT01166737.