Quality of Life After Axillary or Groin Sentinel Lymph Node Biopsy, With or Without Completion Lymph Node Dissection, in Patients With Cutaneous Melanoma

The aim of this study was to asses quality of life (QoL) after axillary or inguinal sentinel lymph node biopsy (SLNB) with or without completion lymph node dissection (CLND) in patients with cutaneous melanoma by comparing patients to a norm group of the general population and by comparing QoL between four patient groups depending on surgical procedure and location, i.e., patients receiving an axillary or groin SLNB, or an axillary or groin CLND.Between 1995 and 2003, a total of 242 axillary and inguinal SLNBs were performed. Of the 127 patients eligible for the study, 116 patients participated (91%). QoL was measured by the 30-item European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), the McGill Pain Questionnaire and the Groningen Activity Restriction Scale.Median age at diagnosis was 50 (range, 18-77) years; median Breslow thickness 2.0 (range, 1-13) mm; median follow-up 56 (range, 4-94) months. SLNB only was performed in 89 patients (77%): 48 in the groin and 41 in the axilla. CLND was performed in 27 patients (23%): 13 in the axilla and 14 in the groin. More postoperative complications (13 vs. 5; P &lt;0.001) and lymphedema (10 vs. 8; P &lt;0.001) occurred in the CLND group than in the SLNB group. The total group of patients reported better physical (P &lt;0.001), role (P &lt;0.001), emotional (P &lt;0.001), and social functioning (P = 0.049), global QoL (P &lt;0.001), and less fatigue (P &lt;0.001) and pain (P &lt;0.001) than a German norm group. Analysis of variance revealed significant differences in role functioning (P = 0.02) and tendencies toward physical problems (P = 0.051) and fatigue (P = 0.051) between the four groups. Post hoc Bonferroni tests showed that the axillary CLND group had more problems than the axillary and inguinal SLNB groups. Kruskal-Wallis tests showed that the axillary CLND group reported most pain.QoL in melanoma survivors after axillary or inguinal SLNB with or without CLND was better than that in a norm group. Patients who underwent CLND in the axilla after SLNB reported most problems.</p

The MELFO-Study:Prospective, Randomized, Clinical Trial for the Evaluation of a Stage-adjusted Reduced Follow-up Schedule in Cutaneous Melanoma Patients-Results after 1 Year

Guidelines for evidence-based follow-up in melanoma patients are not available. This study examined whether a reduced follow-up schedule affects: patient-reported outcome measures, detection of recurrences, and follow-up costs.This multicenter trial included 180 patients treated for AJCC stage IB-II cutaneous melanoma, who were randomized in a conventional follow-up schedule group (CSG, 4 visits first year, n = 93) or experimental follow-up schedule group (ESG, 1-3 visits first year, n = 87). Patients completed the State-Trait Anxiety Inventory, cancer worry scale, impact of events scale, and a health-related quality of life questionnaire (HRQoL, RAND-36). Physicians registered clinicopathologic features and the number of outpatient clinic visits.Sociodemographic and illness-related characteristics were equal in both groups. After 1-year follow-up, the ESG reported significantly less cancer-related stress response symptoms than the CSG (p = 0.01), and comparable anxiety, mental HRQoL, and cancer-related worry. Mean cancer-related worry and stress response symptoms decreased over time (p &lt;0.001), whereas mental HRQoL increased over time (p &lt;0.001) in all melanoma patients. Recurrence rate was 9 % in both groups, mostly patient-detected and not physician-detected (CSG 63 %, ESG 43 %, p = 0.45). Hospital costs of 1-year follow-up were reduced by 45 % in the ESG compared to the CSG.This study shows that the stage-adjusted, reduced follow-up schedule did not negatively affect melanoma patients' mental well-being and the detection of recurrences compared with conventional follow-up as dictated by the Dutch guideline, at 1 year after diagnosis. Additionally, reduced follow-up was associated with significant hospital cost reduction.</p

The MELFO Study:A Multicenter, Prospective, Randomized Clinical Trial on the Effects of a Reduced Stage-Adjusted Follow-Up Schedule on Cutaneous Melanoma IB-IIC Patients-Results After 3 Years

Background This study compares well-being, recurrences, and deaths of early-stage cutaneous melanoma patients in follow-up, as recommended in the Dutch guideline, with that of patients in a stage-adjusted reduced follow-up schedule, 3 years after diagnosis, as well as costs. Methods Overall, 180 eligible pathological American Joint Committee on Cancer (AJCC) stage IB-IIC, sentinel node staged, melanoma patients (response rate = 87%, 48% male, median age 57 years), randomized into a conventional (CSG, n = 93) or experimental (ESG, n = 87) follow-up schedule group, completed patient-reported outcome measures (PROMs) at diagnosis (T1): State-Trait Anxiety Inventory-State version (STAI-S), Cancer Worry Scale (CWS), Impact of Event Scale (IES), and RAND-36 (Mental and Physical Component scales [PCS/MCS]). Three years later (T3), 110 patients (CSG, n = 56; ESG, n = 54) completed PROMs, while 42 declined (23%). Results Repeated measures analyses of variance (ANOVAs) showed a significant group effect on the IES (p = 0.001) in favor of the ESG, and on the RAND-36 PCS (p = 0.02) favoring the CSG. Mean IES and CWS scores decreased significantly over time, while those on the RAND-36 MCS and PCS increased. Effect sizes were small. Twenty-five patients developed a recurrence or second primary melanoma, of whom 13 patients died within 3 years. Cox proportional hazards models showed no differences between groups in recurrence-free survival (hazard ratio [HR] 0.71 [0.32-1.58]; p = 0.400) and disease-free survival (HR 1.24 [0.42-3.71]; p = 0.690). Costs per patient after 3 years (computed for 77.3% of patients) were 39% lower in the ESG. Conclusion These results seemingly support the notion that a stage-adjusted reduced follow-up schedule forms an appropriate, safe, and cost-effective alternative for pathological AJCC stage IB-IIC melanoma patients to the follow-up regimen as advised in the current melanoma guideline

Screening for germline DND1 mutations in testicular cancer patients

Although several observations suggest that a strong genetic predisposition to developing testicular germ cell tumors (TGCT) exists, no associated, highly penetrant germline mutations have been identified so far. In the 129/Sv mouse strain, a germline mutation in the DND1 gene has been shown to strongly increase the TGCT risk. We screened 272 men with TGCT (89% sporadic cases, 11% familial) for germline mutations in the human homologue of DND1. A single nucleotide substitution c.657C > G (p.Asp219Glu) was observed in a non-familial case of testicular embryonal carcinoma. The variant was also present in the patient’s asymptomatic father and two brothers, but not observed in 210 control chromosomes. The wild type DND1 allele was not lost in the patient’s tumor. In silico analysis of the variant predicts it to be non-pathogenic. We conclude that germline DND1 mutations are unlikely to contribute significantly to human testicular germ cell tumor susceptibility. The role of human DND1 in normal physiology and disease, however, is still virtually unknown and it therefore warrants further research

The MelFo Study UK: Effects of a reduced-frequency, stage-adjusted follow-up schedule for cutaneous melanoma 1B to 2C patients after 3-years

Background: Evidence-based guidelines for follow-up treatment of American Joint Committee on Cancer (AJCC) stages 1B to 2C melanoma patients are lacking. The MELanoma FOllow-up study is an international phase 3 randomized trial, and the 3-year interim data were recently reported from the Netherlands. The study was undertaken concurrently with a British cohort for comparison and validation of the Dutch study.  Methods: The study enrolled and stratified 207 patients by AJCC stage. The conventional schedule group (CSG; n = 103) cohort was reviewed as per UK guidelines. The experimental schedule group (ESG; n = 104) cohort was reviewed in a reduced-frequency nurse-led, consultant-supervised clinic. Quality of life (QoL) was measured at baseline (T1), a 1 year (T2), and at 3 years (T3) using the State-Trait Anxiety Inventory, the Cancer Worry Scale, the Impact-of-Event Scale, and the Mental and Physical Component scales (PCS/MCS) of the RAND-36.  Results: Of the 207 QoL questionnaires, 170 (82.1%) were completed at T3. Both cohorts expressed high satisfaction (' 93%) with their regimens. At T3, no significant group effect was found on any patient-reported outcome measures scores, indicating no QoL difference between the follow-up protocols. Recurrence had developed in 33 patients Conventional follow-up (CFU), 16 [15.5%]; Experimental follow-up (EFU), 17 [16.3%]. Self-examination was the method of detection for 12 ESG patients (70.6%) and 11 CSG patients (68.8%). The melanoma-specific survival was identical.  Conclusion: The UK 3-year data were consistent with the previous Dutch report. The reduced follow-up strategy was shown to be safe, with significant resource usage benefits for national cancer services. Patient anxiety levels were not increased by a less-intensive follow-up regimen, and acceptance was high. The study data indicate that patient self-examination is very effective for recurrence detection

Physical functioning and quality of life after cancer rehabilitation

Physical functioning and quality of life after cancer rehabilitation van Weert, E; Hoekstra-Weebers, JEHM; Grol, BMF; Otter, R; Arendzen, JH; Postema, K; van der Schans, CP Con el fin de superar los problemas relacionados con el cá ncer y mejorar la calidad de vida, se desarrolló un programa de rehabilitació n multifocal intensiva para pacientes oncoló gicos. Nuestra hipó tesis era que un programa de rehabilitació n intensiva de seis semanas de duració n se traduciría en mejorías fisioló gicas y de la calidad de vida. Treinta y cuatro pacientes con problemas físicos y psicosociales relacionados con el cá ncer. A´mbito: Centro de rehabilitació n. Disen˜o: Estudio observacional prospectivo. Intervencio´n: Un programa de rehabilitació n multifocal intensiva de seis semanas constituido por cuatro componentes: ejercicio individual, deportes, psicoeducació n e informació n. Criterios de valoracio´n: Ejercicio en bicicleta ergomé trica limitado por los síntomas, fuerza muscular y calidad de vida (RAND-36, RSCL y MFI). Las mediciones se hicieron antes (T0) y despué s de seis semanas de rehabilitació n (T1). Despué s del programa de rehabilitació n intensiva se observaron mejorías estadísti-camente significativas en el ejercicio en bicicleta ergomé trica limitado por los síntomas, en la fuerza muscular y en varios dominios del RAND-36, RSCL y MFI. El programa de rehabilitació n multifocal intensiva de seis semanas tuvo efectos beneficiosos inmediatos sobre las variables fisioló gicas, la calidad de vida y la fatiga

The distress thermometer as a prognostic tool for one-year survival among patients with lung cancer

INTRODUCTION: The use of patient-reported outcome measures is increasingly advocated to support high-quality cancer care. We therefore investigated the added value of the Distress Thermometer (DT) when combined with known predictors to assess one-year survival in patients with lung cancer. METHODS: All patients had newly diagnosed or recurrent lung cancer, started systemic treatment, and participated in the intervention arm of a previously published randomised controlled trial. A Cox proportional hazards model was fitted based on five selected known predictors for survival. The DT-score was added to this model and contrasted to models including the EORTC-QLQ-C30 global QoL score (quality of life) or the HADS total score (symptoms of anxiety and depression). Model performance was evaluated through improvement in the -2 log likelihood, Harrell's C-statistic, and a risk classification. RESULTS: In total, 110 patients were included in the analysis of whom 97 patients accurately completed the DT. Patients with a DT score ≥5 (N = 51) had a lower QoL, more symptoms of anxiety and depression, and a shorter median survival time (7.6 months vs 10.0 months; P = 0.02) than patients with a DT score <5 (N = 46). Addition of the DT resulted in a significant improvement in the accuracy of the model to predict one-year survival (P < 0.001) and the discriminatory value (C-statistic) marginally improved from 0.69 to 0.71. The proportion of patients correctly classified as high risk (≥85% risk of dying within one year) increased from 8% to 28%. Similar model performance was observed when combining the selected predictors with QoL and symptoms of anxiety or depression. CONCLUSIONS: Use of the DT allows clinicians to better identify patients with lung cancer at risk for poor outcomes, to further explore sources of distress, and subsequently personalize care accordingly

A Longitudinal Comparison of Arm Morbidity in Stage I–II Breast Cancer Patients Treated with Sentinel Lymph Node Biopsy, Sentinel Lymph Node Biopsy Followed by Completion Lymph Node Dissection, or Axillary Lymph Node Dissection

Background:\ud Long-term shoulder and arm function following sentinel lymph node biopsy (SLNB) may surpass that following complete axillary lymph node dissection (CLND) or axillary lymph node dissection (ALND). We objectively examined the morbidity and compared outcomes after SLNB, SLNB + CLND, and ALND in stage I/II breast cancer patients.\ud \ud Materials and Methods:\ud Breast cancer patients who had SLNB (n = 51), SLNB + CLND (n = 55), and ALND (n = 65) were physically examined 1 day before surgery (T0), and after 6 (T1), 26 (T2), 52 (T3), and 104 (T4) weeks. Differences in 8 parameters between the affected and unaffected arms were calculated. General linear models were computed to examine time, group, and interaction effects.\ud \ud Results:\ud All outcomes changed significantly, mostly nonlinearly, over time (T0–T4). Between T1 and T4, limitations decreased in abduction (all groups); anteflexion, abduction-exorotation, abduction strength (SLNB + CLND, ALND); flexion strength (SLNB + CLND); and arm volume (SLNB, SLNB + CLND). At T4, limitations in anteflexion (SLNB, ALND), abduction (SLNB + CLND, ALND), exorotation (ALND), abduction-exorotation (all groups), and volume (SLNB + CLND, ALND) increased significantly compared with T0. The SLNB group showed an advantage in anteflexion, abduction, abduction-exorotation, and volume. Groups changed significantly but differently over time in anteflexion, abduction, abduction/exorotation, abduction strength, flexion strength, and volume. Effect sizes varied from 0.19 to 0.00.\ud \ud Conclusion:\ud Initial declines in range of motion and strength were followed by recovery, although not always to presurgery levels. Range of motion and volume outcomes were better for SLNB than ALND, but not strength. SLNB surpassed SLNB + CLND in 2 of the range of motion variables. The clinical relevance of these results is negligible