Diabetes alone should not be a reason for withholding adjuvant chemotherapy for stage III colon cancer

Background: With increasing prevalence of diabetes mellitus and colon cancer, the number of patients suffering from both diseases is growing, and physicians are being faced with complicated treatment decisions. Objective: To investigate the association between diabetes and treatment/course of stage III colon cancer and the association between colon cancer and course of diabetes. Materials and Methods: Additional information was collected from the medical records of all patients with both stage III colon cancer and diabetes (n=201) and a random sample of stage III colon cancer patients without diabetes (n=206) in the area of the population-based Eindhoven Cancer Registry (1998–2007). Results: Colon cancer patients without diabetes were more likely to receive adjuvant chemotherapy compared with diabetic colon cancer patients (OR 1.8; 95% CI 1.2–2.7). After adjustment for age, this difference was borderline significant (OR 1.6; 95% CI 1.0–2.6). Diabetic patients did not have: significantly more side-effects from surgery or adjuvant chemotherapy; more recurrence from colon cancer; significantly shorter time interval until recurrence; or a poorer disease-free survival or overall survival. Age and withholding of adjuvant chemotherapy were most predictive of all-cause mortality. After colon cancer diagnosis, the dose of antiglycaemic medications was increased in 22% of diabetic patients, resulting in significantly lower glycaemic indexes than before colon cancer diagnosis. Conclusions: Since diabetic patients did not have more side-effects of adjuvant chemotherapy, and adjuvant chemotherapy had a positive effect on survival for both patients with and without diabetes, diabetes alone should not be a reason for withholding adjuvant chemotherapy.Journal of Comorbidity 2011;1(1):19–2

Somatostatin analogue continuation upon progression in patients with gastroenteropancreatic neuroendocrine tumour (SAUNA trial):A randomised controlled trial protocol

Introduction Gastroenteropancreatic neuroendocrine tumours (GEP NET) are malignant neoplasms that impact survival. Somatostatin analogues (SSA) are used for treating hormonal symptoms caused by GEP NET and have antiproliferative effects. They are used as first-line therapy in patients with advanced GEP NET, but disease control is limited to a median progression-free survival (mPFS) of 14-32 months. Second-line treatment options include targeted therapy (everolimus or sunitinib), or peptide receptor radionuclide therapy (PRRT) with 177 Lu-DOTATATE. In patients suffering from a NET-related hormonal syndrome, SSA is generally continued life-long. However, there is no consensus on whether it is beneficial to continue SSA in non-functional NET upon disease progression. Due to the ongoing activity of the somatostatin receptor pathway in GEP NET progressing on first-line SSA, we hypothesise that SSA have an added efficacy in second-line therapy. Methods and analysis The SAUNA trial is an international, multicentre, open-label, randomised, controlled, pragmatic clinical trial. 270 patients with advanced, non-functional GEP NET and progression under first-line SSA will be included in substudy 1 (PRRT; n=142) or substudy 2 (targeted therapy (everolimus/sunitinib); n=128) per investigator's choice of second-line therapy and will be randomised (1:1) per substudy between SSA continuation or SSA withdrawal arms. Co-primary endpoints are the difference in progression-free survival (PFS) according to the RECIST (Response Evaluation Criteria In Solid Tumours) V.1.1 criteria and difference in time to deterioration (TTD) in quality of life (QoL) per substudy after initiating second-line therapy with or without SSA. Secondary endpoints include the PFS rate at 18 months, the difference in pooled PFS and TTD combining both substudies, overall survival, response rates, QoL, costs, cost-effectiveness and toxicity. The study design was developed in cooperation with the Belgium and Dutch patient organisations. Ethics and dissemination The study has been approved on 31 May 2023 by the Ethical Committees and Regulatory Authorities of the concerned member states (EU CT number 2022-502703-30-00). Both the trial management group and the steering committee will oversee good governance of this trial. Results of the study will be published in peer-reviewed international journals and presented at international conferences.</p

CLO19-056: Scalp Cooling Proved to be Successful in the Prevention of Alopecia in &gt;7,000 Patients With Solid Tumors

Introduction: Hair loss is a frequently occurring and stigmatizing side effect of chemotherapy. Worldwide scalp cooling is being introduced to prevent chemotherapy-induced alopecia (CIA). In the Netherlands scalp cooling is implemented in many hospitals since 2005. Methods: From 2006–2017, data have been collected in a prospective, longitudinal registry. Patients with all types of solid tumors, with all stages of disease, from all ages and both sexes could participate, if they received a chemotherapy that induced severe hair loss. The hospitals were free to offer scalp cooling to their patients according to their local protocols on cooling and infusion time of the drugs. Patients were eligible for evaluation of hair loss after they received at least 2 cycles of chemotherapy or if they ceased scalp cooling because of severe hair loss after the first cycle. Data will be presented using descriptive statistics and multivariate regression analysis to explore determinants of scalp cooling efficacy. Results: Preliminary results show data of 7,378 patients from 68 hospital locations of whom 75% had breast and 8% prostate cancer. Most patients (61%) were treated in the adjuvant setting. In general, preinfusion cooling time was 30 minutes and postinfusion cooling time 90 minutes. An exception was for docetaxel, for which 20 minutes postinfusion cooling time was used in recent years. Scalp cooling efficacy varied from above 80% for taxanes monotherapy to below 10% for the combination of docetaxel, doxorubicin, and cyclophosphamide (TAC). Results from the regression analyses will be presented at the conference. Conclusion: Scalp cooling proved to be successful for most types of chemotherapy causing CIA.</jats:p

Looking bad: Female patients drawing their representation of chemotherapy-induced alopecia

This study explored the experienced impact of alopecia using patient’s drawings. Forty patients made drawings of their feelings about appearance of their head and hair before and during chemotherapy. Patients also reported illness perceptions (B-IPQ). Twenty-four patients (60%) reported ⩾50% alopecia at enrollment. Most patients (70%) drew a negative change of feelings over time and physical changes. Many experiences related to alopecia emerged from the written texts underneath the drawings and the B-IPQ. Drawings depicted deteriorated feelings of appearance, affecting many activities throughout the day. Healthcare providers are advised to use patient-tailored questioning about alopecia. </jats:p

Diabetes Alone should not be a Reason for Withholding Adjuvant Chemotherapy for Stage III Colon Cancer

Background: With increasing prevalence of diabetes mellitus and colon cancer, the number of patients suffering from both diseases is growing, and physicians are being faced with complicated treatment decisions. Objective: To investigate the association between diabetes and treatment/course of stage III colon cancer and the association between colon cancer and course of diabetes. Materials and Methods: Additional information was collected from the medical records of all patients with both stage III colon cancer and diabetes (n=201) and a random sample of stage III colon cancer patients without diabetes (n=206) in the area of the population-based Eindhoven Cancer Registry (1998–2007). Results: Colon cancer patients without diabetes were more likely to receive adjuvant chemotherapy compared with diabetic colon cancer patients (OR 1.8; 95% CI 1.2–2.7). After adjustment for age, this difference was borderline significant (OR 1.6; 95% CI 1.0–2.6). Diabetic patients did not have: significantly more side-effects from surgery or adjuvant chemotherapy; more recurrence from colon cancer; significantly shorter time interval until recurrence; or a poorer disease-free survival or overall survival. Age and withholding of adjuvant chemotherapy were most predictive of all-cause mortality. After colon cancer diagnosis, the dose of antiglycaemic medications was increased in 22% of diabetic patients, resulting in significantly lower glycaemic indexes than before colon cancer diagnosis. Conclusions: Since diabetic patients did not have more side-effects of adjuvant chemotherapy, and adjuvant chemotherapy had a positive effect on survival for both patients with and without diabetes, diabetes alone should not be a reason for withholding adjuvant chemotherapy