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Contains fulltext : 295913.pdf (Publisher’s version ) (Open Access), BACKGROUND: Fertility-sparing surgery (FSS) is a viable option for young women with early-stage cervical cancer (ECC); however, certain risk factors may necessitate additional treatments and impact fertility. This review examines the prevalence of these risk factors and available treatment options. METHODS: A systematic search was conducted of studies including patients with ECC (IA1 with LVSI, IA2, IB1 (FIGO 2009)) who underwent FSS. RESULTS: Sixty-four articles, comprising a total of 4118 women planned for FSS, were included. High- or intermediate-risk histologic features were found in 638 (15.5%) women: 5.1% had positive lymph node(s), 4.1% had positive resection margins, 0.3% had parametrial involvement, 1.0% had unspecified high-risk features, and 5.1% had intermediate-risk histology (primarily based on the Sedlis criteria). Adjuvant treatment impaired fertility in all women with adjuvant hysterectomy and/or (chemo)radiation (58.7%). Adjuvant chemotherapy was given to 1351 (32.8%) patients, which may reduce fertility. CONCLUSIONS: Fertility preservation could be achieved in most women; but high- or intermediate-risk factors necessitate more extensive surgery or radiotherapy leading to infertility. Adjuvant chemotherapy could be an alternative treatment option considering its effectiveness, safety and higher change in fertility preservation. The low incidence of parametrial involvement justifies waiving parametrectomy in tumors < 2 cm.

Contains fulltext : 242806.pdf (Publisher’s version ) (Open Access)

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Contains fulltext : 207171.pdf (publisher's version ) (Open Access)

Contains fulltext : 202048.pdf (publisher's version ) (Closed access)

Item does not contain fulltext, BACKGROUND AND PURPOSE: Creating an individualized tissue equivalent material build-up (i.e. bolus) for electron beam radiation therapy is complex and highly labour-intensive. We implemented a new clinical workflow in which 3D printing technology is used to create the bolus. MATERIAL AND METHODS: A patient-specific bolus is designed in the treatment planning system (TPS) and a shell around it is created in the TPS. The shell is printed and subsequently filled with silicone rubber to make the bolus. Before clinical implementation we performed a planning study with 11 patients to evaluate the difference in tumour coverage between the designed 3D-print bolus and the clinically delivered plan with manually created bolus. For the first 15 clinical patients a second CT scan with the 3D-print bolus was performed to verify the geometrical accuracy. RESULTS: The planning study showed that the V85% of the CTV was on average 97% (3D-print) vs 88% (conventional). Geometric comparison of the 3D-print bolus to the originally contoured bolus showed a high similarity (DSC=0.89). The dose distributions on the second CT scan with the 3D print bolus in position showed only small differences in comparison to the original planning CT scan. CONCLUSIONS: The implemented workflow is feasible, patient friendly, safe, and results in high quality dose distributions. This new technique increases time efficiency.

Item does not contain fulltext, BACKGROUND: Tumor volume is an important predictor of outcome in radiotherapy alone. Its significance in concomitant chemoradiation (CCRT) is much less clear. We analyzed the prognostic value of primary tumor volume for advanced head and neck squamous cell carcinoma (HNSCC) treated with CCRT. METHODS: Three hundred sixty patients treated with definitive CCRT for advanced HNSCC were selected. The pretreatment MRI or CT scan was used to calculate the primary tumor volume. Median follow-up was 19.8 months. RESULTS: The average primary tumor volume was 37.0 cm(3) (range, 2.1-182.7 cm(3); median, 28.7 cm(3)). Multivariate analysis showed a significant effect of tumor volume on local control. The hazard ratio for a local recurrence increased by 14% per 10 cm(3) volume increase (95% CI, 8% to 21%). There was no significant independent effect of T and N status on local control. CONCLUSION: For advanced HNSCC, tumor volume is more powerful for predicting outcome after CCRT than TNM status.

Contains fulltext : 96401.pdf (publisher's version ) (Open Access)

Contains fulltext : 52824.pdf (publisher's version ) (Closed access), PURPOSE: To validate the recursive partitioning analysis (RPA) classification system for squamous cell head and neck cancer as recently reported by the VU University Medical Center. METHODS AND MATERIALS: In eight Dutch head and neck cancer centers, data necessary to classify patients according to the RPA system were retrospectively collected from the charts of a group of 780 patients treated between 1989 and 2003. The patients in this validation group were classified according to the RPA classification system. For each endpoint, the 5-year values and hazard ratios were calculated and compared with the results of the VU University Medical Center. The RPA classification system was considered valid if the hazard ratio of the validation population was within the 95% confidence interval of the VU University Medical Center study population. RESULTS: The locoregional control rate was 82%, 75%, and 63% at 5 years for those with class I, II, and III, respectively (p < 0.0001). The hazard ratio for the locoregional control rate relative to class I was 1.44 (95% confidence interval, 0.97-2.16) for class II and 2.37 (95% confidence interval, 1.57-3.57) for class III. Similar results were found for the distant metastasis, overall survival, and disease-free survival rates. CONCLUSION: The RPA classification system for head and neck squamous cell carcinoma in the postoperative setting, which was originally designed at one center, proved to be valid in a multicenter setting among patients included in a national multicenter study. This validated RPA classification scheme can be used to assess standard treatment strategies for head and neck squamous cell carcinoma in the postoperative setting, as well as in the design of future prospective studies.

KUN Katholieke Universiteit Nijmegen, 21 februari 2005, Promotor : Daal, W.A.J. van Co-promotores : Stalmeier, P.F.M., Verhoef, C.G., Item does not contain fulltext, Women with a BRCA1/2 mutation have a high genetic risk of developing breast and ovarian cancer. They face the difficult choice between screening and prophylactic surgery for the breasts and ovaries. We have developed a shared decision making program to prepare these women for decision making. The shared decision making program consisted of two decision aids. The decision aids have been developed as adjuncts to standard genetic counselling and were evaluated in a randomized trial. The study included both women affected and unaffected with cancer testing for a BRCA1/2 mutation. The first decision aid consisted of a brochure and video providing information on screening and prophylactic surgery and their consequences. It was provided either before or after the DNA-test result. This decision aid had no impact on well-being neither on decision related outcomes. Beneficial effects were found on information related outcomes. These effects occurred irrespective whether the decision aid was presented before or after the DNA-test result. No interaction effect was found between the DA and the personal history of cancer. The second decision aid consisted of two value assessment sessions, using the time trade-off method, followed by individualized treatment information based on (quality adjusted) life expectancy derived form a decision model. This decision aid only had an effect on the long term (9 months after the test result). Women reported less intrusive thoughts about cancer, a better general health, and tended to be less depressed. Furthermore, the SDMI strengthened treatment preferences and increased the feeling of having weighed the pros and cons. A differential impact was found in women affected with cancer versus unaffected women. Unaffected women benefited from this decision aid, while affected women tended to experience detrimental effects. The effects of the two decision aids are complementary. Thus, preferably, the complete support package should be offered.

Contains fulltext : 48202.pdf (publisher's version ) (Closed access), There are several instruments to assess how patients evaluate their medical treatment choice. These are used to evaluate decision aids. Our objective is to investigate which psychological factors play a role when patients evaluate their medical treatment choices. A pool of 36 items was constructed, covering concepts such as uncertainty about and satisfaction with the decision, informed choice, effective decision making, responsibility for the decision, perceived riskiness of the choice, and social support regarding the decision. This pool was presented to patients at high risk for breast and ovarian cancer, awaiting a genetic test result, and facing the choice between prophylactic surgery or screening. Additional measures were assessed for validation purposes. Factor and Rasch analyses were used for factor and item selection. Construct validity of emerging scales was assessed by relating them with the additional measures. Three factors summarised the psychological factors concerning decision evaluation: Satisfaction-Uncertainty, Informed Choice, and Decision Control. Reliabilities (Cronbach's alpha) of the three scales were 0.79, 0.85, and 0.75, respectively. Construct validity hypotheses were confirmed. The first two scales were similar to previously developed scales. Of these three scales, the Decision Control scale correlated most strongly with the well-being measures, was associated with partner's agreement and physician's preferences as perceived by patients, and with a negative emotional reaction to the information material. In conclusion, the Decision Control scale is a new scale to evaluate decision aids, and it appears to be rooted in health psychological theories.

Contains fulltext : 57884.pdf (publisher's version ) (Open Access), PURPOSE: To evaluate a shared decision-making intervention (SDMI) for BRCA1/2 mutation carriers who have to make a choice between screening and prophylactic surgery for breasts and/or ovaries. PATIENTS AND METHODS: The SDMI consisted of two value assessment sessions, using the time trade-off method, followed by individualized treatment information based on (quality-adjusted) life expectancy. After the baseline assessment (2 weeks after a positive DNA test result), women were randomly assigned to the SDMI group (n = 44), receiving the SDMI 2 months after the test result, or to the control group (n = 44). The short- and long-term effects, 3 and 9 months after the test result, were assessed using questionnaires. Data were collected on well-being, treatment choice, and decision-related outcomes. RESULTS: In the short term, the SDMI had no effect. In the long term, with respect to well-being, patients in the SDMI group had less intrusive thoughts (P =.05) and better general health (P =.01) and tended to be less depressed (P =.07). With respect to decision-related outcomes for the breasts, the SDMI group held stronger preferences (P =.02) and agreed more strongly to having weighed the pros and cons (P =.01). No effect was found on treatment choice. In the long term, interaction effects between the SDMI and cancer history were found. The SDMI showed an overall beneficial effect for unaffected women, whereas affected women tended to experience detrimental effects. CONCLUSION: We conclude that the SDMI improved decision making in unaffected BRCA1/2 mutation carriers. Supporting decision making in a systematic way using trade-offs is beneficial for these women.

Contains fulltext : 57882.pdf (publisher's version ) (Closed access), The aim of the study was to evaluate the impact of a decision aid (DA) and its timing in women being tested for a BRCA1/2 mutation. Women with and without a previous history of cancer were included after blood sampling for genetic testing. The DA consisted of a brochure and video providing information on screening and prophylactic surgery. To evaluate the impact of the DA, women were randomised to the DA group (n=184), receiving the DA 2 weeks after blood sampling, or to the control group (n=184). To evaluate the impact of timing, mutation carriers who had received the DA before the test result (n=47) were compared to mutation carriers who received the DA after the test result (n=42). Data were collected on well-being, treatment choice, decision and information related outcomes. The impact of the DA was measured 4 weeks after blood sampling. The impact of timing was measured 2 weeks after a positive test result. The DA had no impact on well-being. Regarding decision related outcomes, the DA group more frequently considered prophylactic surgery (P=0.02) corroborated with higher valuations (P=0.04). No differences were found for the other decision related outcomes. Regarding information related outcomes, the DA group felt better informed (P=0.00), was more satisfied with the information (P=0.00), and showed more accurate risk perceptions. Timing of the DA had no effect on any of the outcomes. No interactions were found between the DA and history of cancer. In conclusion, women being tested for a BRCA1/2 mutation benefit from the DA on information related outcomes. Because timing had no effect, the DA is considered useful either before or after the test result.

Item does not contain fulltext, PURPOSE: BRCA1 mutation carriers have a high risk of developing breast and ovarian cancer. Carriers may opt for prophylactic surgery and screening. Recent data suggesting that prophylactic oophorectomy reduces breast cancer risk have been incorporated in a decision analysis. METHODS: A Markov model was developed to compare LE and QALE following four strategies: (1) prophylactic mastectomy and prophylactic oophorectomy (PMPO), (2) screening for breast cancer and prophylactic oophorectomy (BSPO), (3) prophylactic mastectomy and screening for ovarian cancer (PMOS), and (4) screening for breast and ovarian cancer (BSOS). The analysis was performed for a high (85% breast cancer, 63% ovarian cancer) and medium (56% breast cancer, 16% ovarian cancer) risk level. Utilities for the health states after prophylactic surgery were obtained from mutation carriers. Other model parameter values were obtained from the literature. Sensitivity analyses were performed. RESULTS: When compared with BSOS, the average gain in LE for 30-year-old carriers in the high (medium) risk group was 11.7 (6.6) years for PMPO, 9.5 (5.3) years for BSPO, and 4.9 (4.4) years for PMOS. For 30-year-old carriers, BSPO had a QALE advantage when PO was performed before age 40. In the medium-risk group, there was a stronger advantage for BSPO when QALE was considered. CONCLUSION: PMPO is the most effective strategy to prolong life. However, if patient preferences were taken into account, BSPO tends to be a better strategy in most women at medium risk or in young women at high risk when PO was performed before age 40.

Contains fulltext : 122189.pdf (publisher's version ) (Closed access), This pilot study determines fast dynamic gadolinium enhanced MRI contrast enhancement parameters (onset of enhancement and time to peak enhancement) before and after radiotherapy in 10 cervical carcinoma patients. Before radiotherapy, onset of enhancement and time to peak enhancement were early, with a median of 4.5 and 5.2 seconds, respectively. High-grade tumors showed early enhancement, compared with low-grade. After radiotherapy, contrast enhancement patterns differed. In survivors, onset of enhancement after radiotherapy was later than before radiotherapy. In non-survivors, onset of enhancement after radiotherapy was still early. The median difference in onset of enhancement before and after radiotherapy in survivors and non-survivors was an increase of 3.2 and a decrease of 1.1 seconds, respectively. Early onset of enhancement after radiotherapy was a better predictor for survival than a high-signal intensity zone on post radiotherapy unenhanced T1/T2-weighted MRI. It is concluded that enhancement parameters from fast dynamic Gd-enhanced MR images can provide additional functional information with regard to tumor vascularization, and may have prognostic significance. It complements clinical examination and unenhanced MRI in determining the effectiveness of radiotherapy treatment in cervical carcinoma. Future studies will focus on the clinical utility and improvements of the estimation of contrast-enhanced parameters with this new technique.

Item does not contain fulltext, Women with a suspected BRCA1/2-mutation may choose between two management options: breast cancer screening or prophylactic mastectomy (PM). Objectives. To compare women's treatment choices, medical and decision analytic recommendations, and to explore variables related to the women's treatment choices. Methods. After provision of information, individual Time tradeoff values for the health outcome 'living after PM' were assessed and incorporated into a decision analytic model, which compared the management options PM and screening with respect to their effect on quality-adjusted life expectancy. Results. Of the 54 women with a suspected BRCA1/2-mutation, 51 women completed the shared decision making procedure. Quality-adjusted life expectancy after PM management was longer for 67% of proven carriers and for 58% of women awaiting the DNA-test result. Twelve proven carriers made a definitive treatment choice; it was the management option PM in eight (67%) and screening in four cases (33%). All carriers treatment choices agreed with the normative decision analytic recommendation. Four carriers (33%) disagreed with the medical recommendations. Of the 36 women awaiting the DNA-test result, 32 made a hypothetical treatment choice. The agreement between these hypothetical treatment choices and the decision analytic recommendation was good (78%). Combining data from all 48 women, being married (OR = 14.00, p = 0.006), having children (OR = 4.71, p = 0.02), a low Desire to Participate (OR = 0.14, p = 0.004), high Decisional stress (OR = 5.22, p = 0.01), a lower estimate of the 'probability of cure for screen-detected breast cancer' (OR = 0.13, p = 0.004), and higher Time tradeoff values for PM (OR = 182, p < 0.0001) made a choice for PM more likely. Conclusions. There was complete agreement between the decision analytic recommendation and the carriers' treatment choices. This suggests that women act in accordance with normative decision theory. The disagreement between the

Item does not contain fulltext, Women with a suspected genetic predisposition for breast cancer face the difficult choice between participation in a breast cancer screening program and prophylactic mastectomy. We developed a Shared Decision Making Program (SDMP) to support this decision. Objectives. To evaluate the SDMP on practicality, beneficial effects, and satisfaction. Design. A one-group pretest-posttest design was used. Measures. The measures comprised decision uncertainty, decision burden, subjective knowledge and risk comprehension: these were assessed before and after the SDMP. Additional measures were obtained for concepts related to breast cancer concern, wish to participate, satisfaction, acceptability, and emotional reaction to information material. Results. Seventy-two women, most of whom were awaiting the genetic test results, participated. Decision uncertainty (effect size d = 0.37) and decision burden (d = 0.41) improved. Subjective knowledge (averaged d = 0.94) and risk comprehension also improved. Women were satisfied with the SDMP and found its rationale acceptable. Women with a strong emotional reaction to the information material benefited less, whereas women with a stronger wish to participate in the decision benefited more from the SDMP. Conclusions. There is a need for more information, especially on prophylactic mastectomy and among gene carriers. Beneficial effects were observed both for women with unknown and known genetic status. This suggests that information concerning treatment options should be made available as soon as DNA testing begins. Better psychological outcomes for women with a stronger wish to participate may arise because wish to participate items are characteristic of an emotionally stable personality. Key words: shared decision making; breast cancer; genetic predisposition; patient participation; patient satisfaction.

KUN, 19 januari 1999, Promotor : Daal, W.A.J. van Co-promotores : Verhoef, C.G., Stalmeier, P.F.M., Brunner, H.G., Boonstra, H., Haes, J.C.J.M. de, Item does not contain fulltext

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