Real-world data on niraparib maintenance treatment in patients with non-gBRCA mutated platinum-sensitive recurrent ovarian cancer.

OBJECTIVES: The aim of this study was to provide real-world efficacy and safety data on niraparib maintenance treatment in patients with non-germline (gBRCA)1/2 mutated platinum-sensitive recurrent ovarian cancer. METHODS: This retrospective multi-center cohort study included 94 platinum-sensitive recurrent ovarian cancer patients without known gBRCA1/2 mutation treated in an individual patient access program in Norway. The primary outcome was time from start of niraparib treatment to first subsequent treatment. Secondary endpoints included progression-free survival, safety, and tolerability. RESULTS: After median follow-up of 13.4 months (95% confidence interval (CI) 10.0 to 16.8), 68.1% had progressed and 22.3% had died. Of the entire cohort, 61.7% had commenced a new line of treatment, and 24.5% were still receiving niraparib. The median duration of niraparib treatment was 5.0 months (range 0.4 to 27.3), and the median time to first subsequent treatment was 10.7 months (95% CI 8.4 to 13.0). Patients with elevated CA125 prior to start of niraparib had shorter time to first subsequent treatment (7.3 months, 95% CI 4.2 to 10.3) than patients with normalized CA125 (12.2 months, 95% CI 10.9 to 13.7 (p=0.002). Patients who started on individual dose based on weight and platelet counts had fewer dose reductions (p<0.001) and interruptions (p=0.02). CONCLUSION: In a real-world setting, niraparib maintenance treatment in patients with non-gBRCA1/2 mutated recurrent platinum-sensitive ovarian cancer showed effectiveness comparable with published phase III studies and acceptable safety. Individualized dosing is essential to minimize adverse events. CA125 levels at start of niraparib treatment may help to estimate the individual prognosis.

A study of modifiable factors associated with health-related quality of life in long-term cervical cancer survivors.

INTRODUCTION: Health-related quality of life (HR-QoL) in cancer survivors is relevant for symptom relief and optimal care. The aim of this cross-sectional study of long-term cervical cancer survivors was two-fold: (a) To compare HR-QoL in long-term cervical cancer survivors with reference data; and (b) to identify modifiable factors significantly associated with low levels of generic cancer HR-QoL in long-term cervical cancer survivors using high HR-QoL as reference. MATERIAL AND METHODS: Women treated for cervical cancer from 2000 through 2007 who were cancer-free and alive in 2013 received a mailed questionnaire including scales for anxiety, depression, and HR-QoL. To obtain a homogeneous sample only women with FIGO stages 1 and 2 were included. The questionnaire included the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire.C-30 (EORTC QLQ C-30) for generic HR-QoL. Groups with high and low HR-QoL were defined by the median score on the general HR-QoL item. Between-group differences were examined with descriptive statistics. Logistic regression analyses examined independent variables associated with low generic HR-QoL. RESULTS: Complete C-30 scores were delivered by 472 long-term cervical cancer survivors. Median age at survey was 53 (interquartile range 14.9) years, and median time since diagnosis was 11 (interquartile range 3.9) years. The proportion of survivors with stage 1 disease was 83% and stage 2 was 17%. Mean generic HR-QoL scores showed minor differences between long-term cervical cancer survivors and reference data. In the multivariable analysis, only modifiable variables remained significantly associated with low generic HR-QoL namely self-rated health, probable depression, fatigue, and pain. In bivariate analyses other modifiable variables also showed significant associations with low generic HR-QoL like probable anxiety disorder, obesity, smoking, sleep disturbances, and bowel symptoms. CONCLUSIONS: Clinicians should be aware that generic HR-QoL in long-term cervical cancer survivors eventually may be improved by identification and treatment of modifiable factors through the whole follow-up period.

Sexual Inactivity During the Last 4 Weeks in Long-Term Cervical Cancer Survivors: Prevalence and Associated Factors.

BACKGROUND: Most studies of cervical cancer (CC) survivors describe sexual inactivity in relation to treatment modalities, but few consider that inactivity varies with age and partner status. AIM: The aim of this study was to investigate the prevalence of sexual inactivity in long-term CC survivors according to age and partner status, and to examine cancer-related, health, demographic, and psychological factors related to sexual inactivity. METHODS: All 974 women treated for CC from 2000 through 2007 in 2 areas of Norway, who were alive and cancer-free by the end of 2013, received a mailed questionnaire. Among them, 523 delivered valid data on current sexual activity (response rate 57%). The prevalence rates of sexual inactivity in relation to age groups and partner status were compared to normative sample (NORMs). MAIN OUTCOME MEASURE: Sexual inactivity during the 4 weeks before the survey was administered. RESULTS: Median age of the sample at survey was 53 years (range 32-77) and median time since diagnosis was 11 years (range 6-15). Of the survivors aged 35-69 years, 39% (95% CI 35-44%) were sexually inactive at survey compared to 36% (95% CI 32-38%) in the NORMs. Compared with sexually active survivors, inactive ones were significantly older, more frequently had single partner status, and had less frequently been childbearing. Inactive survivors more frequently had low education, did not hold paid work at survey, had poorer self-rated health, and were more often obese. They also had higher prevalence of depression, high neuroticism, and chronic fatigue. On most cancer-related quality of life measures, sexually inactive survivors had significantly lower mean scores than sexually active ones. They significantly more often had been treated with chemotherapy and/or radiation than with conization or major surgery. In multivariable regression analysis, only older age, no prior childbearing, and single partner status remained significantly associated with sexual inactivity. CLINICAL IMPLICATIONS: Sociodemographic variables may be more relevant than clinical and cancer-related variables concerning sexual inactivity in long-term CC survivors. STRENGTHS & LIMITATIONS: Our study had a considerable sample size and used instruments with established psychometric qualities. The moderate response rates of the study and of the NORMs imply risks for selection biases. CONCLUSION: Close to 4 in 10 survivors were sexually inactive which is similar to the rate among NORMs. Demographic factors were most strongly associated with sexual inactivity. Some other significant factors are eventually amenable to treatment and should be checked by the health-care providers. Dahl AA, Bentzen AG, Fosså SD, et al. Sexual Inactivity During the Last 4 Weeks in Long-Term Cervical Cancer Survivors: Prevalence and Associated Factors. J Sex Med 2020;17:1359-1369.

Long-term cervical cancer survivors on disability pension: a subgroup in need of attention from health care providers.

PURPOSE: Survivors of cervical cancer have an increased risk for permanently reduced work ability qualifying for disability pension (DP). Few studies describe the social and health situation of long-term survivors of cervical cancer (LSCCs) on DP as a subgroup among LSCCs. The purpose was to investigate the socio-demographic and health status of LSCCs holding DP in a population-based cohort using LSCCs holding paid work as reference. METHODS: Altogether, 354 LSCCs under 67 years (age of retirement pension in Norway) at survey participated in this study. They responded to a mailed questionnaire containing social, health, and clinical issues. RESULTS: Among LSCCs 24% held DP at a median of 11 years (range 6-15) after diagnosis versus 12% in the general female population. Compared to LSCCs in paid work, those on DP had significantly higher mean age at survey, short education, more comorbid somatic diseases, poorer self-rated health, higher level of neurotoxic side effects, more chronic fatigue, and higher mean levels of anxiety and depression. Increased age, presence of musculo-skeletal diseases, and increased levels of depression and pain remained significantly associated with DP in multivariate analysis. CONCLUSIONS: One in four LSCCs held DP which was twice the rate of the general female population. Several somatic and psychological conditions amenable to treatment were significantly associated with holding DP. IMPLICATIONS FOR CANCER SURVIVORS: LSCCs holding DP should check their health regularly since conditions that can be treated are common, and health care providers should be aware of this opportunity.

Faecal incontinence after chemoradiotherapy in anal cancer survivors: long-term results of a national cohort.

PURPOSE: To examine the prevalence and severity of faecal incontinence amongst anal cancer survivors after chemoradiotherapy. MATERIAL AND METHODS: Anal cancer survivors from a complete, unselected, national cohort, minimum 2-years follow-up, were invited to a cross-sectional study. The St. Mark's incontinence score was used to evaluate occurrence and degree of faecal incontinence the last four weeks. The results were compared to age- and sex-matched volunteers from the general population. RESULTS: Of 199 invited survivors and 1211 volunteers, 66% and 21%, respectively, signed informed consent. The survivors had significantly higher St. Mark's score than the volunteers (mean 9.7 vs. 1.1, p<0.001). Incontinence of stool of any degree was reported by 43% vs. 5% (OR 4.0, CI 2.73-6.01), and urgency was reported by 64% vs. 6% (OR 6.6, CI 4.38-9.90) of the survivors and volunteers, respectively. Only 29% of those with leakage of liquid stool used constipating drugs. Survivors of locally advanced tumours had a higher incontinence score (p<0.01). CONCLUSIONS: Moderate to severe faecal incontinence is common amongst anal cancer survivors. Post-treatment follow-up should include the evaluation of continence, and incontinent survivors should be offered better symptom management and multidisciplinary approach if simple measures are insufficient.

Impaired health-related quality of life after chemoradiotherapy for anal cancer: late effects in a national cohort of 128 survivors.

BACKGROUND: Chemoradiotherapy is an effective treatment for anal cancer, yet from follow-up many survivors seem to suffer from late effects. Data of long-term health-related quality of life (HRQOL) in anal cancer survivors are limited, and there is a growing interest in cancer survivorship. MATERIAL AND METHODS: A national cohort of all anal cancer survivors treated with curative chemoradiotherapy in 2000-2007 was invited to a cross-sectional study. Of 199 eligible survivors, 128 (64%) returned the questionnaires, the median time since diagnosis was 66 months. The median age was 61 years and 79% were women. HRQOL was evaluated with EORTC questionnaires QLQ-C30 and QLQ-CR29, and neurotoxicity with the Scale of Chemotherapy-Induced Neurotoxicity. An age- and sex-matched reference group of volunteers (n = 269) not treated for pelvic cancer answered the same questionnaires. Results from QLQ-C30 of the reference group were compared to Norwegian and Dutch normative data. RESULTS: The mean scores of anal cancer survivors were poorer compared to volunteers and normative data. Anal cancer survivors reported significant impairment of function, especially social and role function, compared to the volunteers (difference ≥ 20 points, p < 0.001). Survivors had markedly increased scores for fatigue, dyspnoea, insomnia and diarrhoea (difference ≥ 15 points, p < 0.001). The global quality of life was significantly reduced (difference 15 points, p < 0.001). Anal cancer survivors had increased stool frequency, more buttock pain, flatulence, faecal incontinence, impotence (males), dyspareunia and reduced sexual interest (females) (difference ≥ 15 points, p < 0.001). There was increased frequency of tinnitus in survivors treated with cisplatin-based chemotherapy (p = 0.004). CONCLUSIONS: Survivors after chemoradiotherapy for anal cancer have significant long-term impairment of HRQOL. Reduced social, role and sexual function, and increased diarrhoea, incontinence for gas and stools, and buttock pain were commonly reported. Increased awareness of this may lead to better management of late effects and better care for cancer survivors.

Chemoradiotherapy of anal carcinoma: survival and recurrence in an unselected national cohort.

PURPOSE: To evaluate treatment results, elucidate whether national guidelines were followed, and identify areas demanding further treatment optimization. METHODS AND MATERIAL: Between July 2000 and June 2007, 328 patients were treated with curatively intended chemoradiotherapy (CRT) for nonmetastatic squamous cell carcinoma of the anal region, according to national treatment guidelines based on tumor stage. RESULTS: Complete response after CRT was obtained in 87% of patients, rising to 93% after salvage surgery. Chemotherapy, elective irradiation of the groin and salvage surgery were performed to a lesser extent in elderly patients, mainly because of frailty and comorbidity. Recurrence occurred in 24% of the patients, resulting in a 3- and 5-year recurrence-free survival (RFS) of 79% and 74%, respectively. Locoregional recurrences dominated, most commonly in the primary tumor site. Recurrence was treated with curative intent in 45% of the cases. The 3- and 5-year overall survival were 79% and 66%, and cancer-specific survival (CSS) were 84% and 75%, respectively. The risk of adverse outcome increased significantly with more locally advanced tumors and for male gender in multivariable analyses for RFS and CSS. CONCLUSIONS: The treatment results are in accordance with similar cohorts. The primary treatment control rate was high, but there was a significant risk of locoregional recurrence in advanced tumors. The loyalty to national guidelines was broad, although individual adjustments occurred. However, caution to avoid toxicity must not lead to inadequate treatment. Male gender seems to have inferior outcome.

[Recurrence of rectal cancer--treatment in Norwegian hospitals]. / Residiv av endetarmskreft--synspunkter på behandling.

BACKGROUND: The aim of this study was to examine if Norwegian surgeons had a passive attitude to treatment of patients with local recurrence of rectal cancer after primary treatment and if attitudes to treatment differed between hospitals. MATERIAL AND METHODS: All 46 departments for gastrointestinal surgery in Norway answered a questionnaire detailing their policy for workup, referral and treatment of patients with pelvic recurrence after surgery for rectal cancer. RESULTS: All hospitals used MRI for evaluation of the pelvis. Most clinics initially considered the patients potentially curable. Many wished to refer the patients to hospitals with more competence. Most patients in Norway are treated in eight different departments. Most of the surgeons give preoperative chemoradiotherapy before surgical resection of the local recurrence. INTERPRETATION: There seems to be a reasonable consensus among Norwegian surgeons about treatment of recurrent rectal cancer. The doctors themselves have to a certain degree centralized the treatment. Patients with recurrent rectal cancer should be discussed in multidisciplinary teams.