Background: Ripretinib is a novel switch-control kinase inhibitor that inhibits KIT and PDGFRA signaling. In the INVICTUS phase 3 trial, ripretinib increased median progression-free survival and... Show moreBackground: Ripretinib is a novel switch-control kinase inhibitor that inhibits KIT and PDGFRA signaling. In the INVICTUS phase 3 trial, ripretinib increased median progression-free survival and prolonged overall survival vs. placebo in >= fourth-line advanced GIST. Here, we report prespecified analysis of quality of life (QoL) as assessed by patient-reported outcome (PRO) measures and an exploratory analysis evaluating the impact of alopecia on QoL. Methods: In the INVICTUS trial (NCT03353753), QoL was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30; physical function, role function, overall health, and overall QoL) and the EuroQoL 5-Dimension 5-Level (EQ-5D-5 L; visual analogue scale). Analysis of covariance (ANCOVA) models compared changes in scores from baseline to treatment cycle 2, day 1 within and between ripretinib and placebo. Within the ripretinib arm, repeated measures models assessed the impact of alopecia on QoL. Results: Patients receiving ripretinib maintained QoL (as assessed by the EORTC QLQ-C30 and EQ-5D-5 L PRO measures) from baseline to cycle 2, day 1 whereas QoL declined with placebo, resulting in clinically significant differences between treatments (nominal P < 0.01). The most common treatment-emergent adverse event with ripretinib was alopecia; however, QoL was similarly maintained out to treatment cycle 10, day 1 in patients receiving ripretinib who developed alopecia and those who did not. Conclusion: PRO assessments in the INVICTUS trial suggest that patients on ripretinib maintain their QoL out to C2D1, unlike patients receiving placebo. Longitudinal QoL was maintained for patients receiving ripretinib out to cycle 10, day 1 (approximately 8 months; past the point of median progression-free survival with ripretinib [6.3 months]), even if the patients developed alopecia. Show less
Schoeffski, P.; George, S.; Heinrich, M.C.; Zalcberg, J.R.; Bauer, S.; Gelderblom, H.; ... ; Mehren, M. von 2022
Background: Ripretinib is a novel switch-control kinase inhibitor that inhibits KIT and PDGFRA signaling. In the INVIC‑ TUS phase 3 trial, ripretinib increased median progression-free survival and... Show moreBackground: Ripretinib is a novel switch-control kinase inhibitor that inhibits KIT and PDGFRA signaling. In the INVIC‑ TUS phase 3 trial, ripretinib increased median progression-free survival and prolonged overall survival vs. placebo in ≥fourth-line advanced GIST. Here, we report prespecifed analysis of quality of life (QoL) as assessed by patientreported outcome (PRO) measures and an exploratory analysis evaluating the impact of alopecia on QoL. Methods: In the INVICTUS trial (NCT03353753), QoL was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30; physical function, role function, overall health, and overall QoL) and the EuroQoL 5-Dimension 5-Level (EQ-5D-5 L; visual analogue scale). Analysis of covari‑ ance (ANCOVA) models compared changes in scores from baseline to treatment cycle 2, day 1 within and between ripretinib and placebo. Within the ripretinib arm, repeated measures models assessed the impact of alopecia on QoL. Results: Patients receiving ripretinib maintained QoL (as assessed by the EORTC QLQ-C30 and EQ-5D-5 L PRO meas‑ ures) from baseline to cycle 2, day 1 whereas QoL declined with placebo, resulting in clinically signifcant diferences between treatments (nominal P<0.01). The most common treatment-emergent adverse event with ripretinib was alopecia; however, QoL was similarly maintained out to treatment cycle 10, day 1 in patients receiving ripretinib who developed alopecia and those who did not. Conclusion: PRO assessments in the INVICTUS trial suggest that patients on ripretinib maintain their QoL out to C2D1, unlike patients receiving placebo. Longitudinal QoL was maintained for patients receiving ripretinib out to cycle 10, day 1 (approximately 8 months; past the point of median progression-free survival with ripretinib [6.3 months]), even if the patients developed alopecia. Show less
Purpose: Scalp cooling can prevent chemotherapy-induced alopecia (CIA). Previously, the post-infusion cooling time (PICT) could be successfully reduced in docetaxel-treated patients from 90 to 45... Show morePurpose: Scalp cooling can prevent chemotherapy-induced alopecia (CIA). Previously, the post-infusion cooling time (PICT) could be successfully reduced in docetaxel-treated patients from 90 to 45 and 20 min. Therefore, it seems plausible that the PICT can be shortened for paclitaxel-treated patients as well. Methods: Patients treated with weekly paclitaxel were included in this multi-centre trial and randomly assigned to a PICT of 45 or 20 min. The results were compared to a standard PICT of 90 min, derived from prospective collected data from the Dutch Scalp Cooling Registry. The primary endpoint was the percentage of patients who decide to not wear a wig or head covering. Secondary endpoints were the degree of CIA assessed with the Dean scale for assessment of hair loss; alopecia graded according to NCI CTC toxicity version 4.03 (CTCAE4.03); tolerance of scalp cooling and perceived distress of CIA. Results: Ninety-one patients were enrolled in this study; 74 patients were evaluable for hair loss. Hair preservation was successful in 27 patients (75%) with a PICT of 45 min and in 31 patients (82%) with a PICT of 20 min. There was no difference in success rate with the standard PICT of 90 min (85%, p = 0.29). Similar success rates were seen when using the Dean scale and CTCAE assessment, with no differences between groups (p = 0.12 and p = 0.38). Conclusions: A 20 min PICT is as effective as 45 and 90 min to prevent weekly paclitaxel-induced alopecia and should be the new standard of care. Show less
Door de toepassing van hoofdhuidkoeling kan haaruitval worden verminderd of voorkomen. Hoofdhuidkoeling heeft, afhankelijk van de soort chemotherapie, bij ongeveer 50% van de patiënten een positief... Show moreDoor de toepassing van hoofdhuidkoeling kan haaruitval worden verminderd of voorkomen. Hoofdhuidkoeling heeft, afhankelijk van de soort chemotherapie, bij ongeveer 50% van de patiënten een positief effect. Farmacologische interventies om haaruitval te voorkomen zijn niet toereikend. De incidentie van haaruitval kan verminderd worden door de methode van hoofdhuidkoeling te optimaliseren.De afgelopen jaren is door het Leids Universitair Medisch Centrum, Noordwest Ziekenhuisgoep en Integraal Kankercentrum Nederland in samenwerking met verschillende ziekenhuizen in Nederland onderzoek verricht naar factoren die van invloed kunnen zijn op het effect van hoofdhuidkoeling. Show less
Alphen, K. van; Versluis, A.; Dercksen, W.; Haas, H. de; Lugtenberg, R.; Tiemensma, J.; ... ; Hurk, C. van den 2020
Objective: Individuals with cancer experience the impact of chemotherapy on hair loss in different ways. The aim of this pilot study was to explore patients' experiences of alopecia through... Show moreObjective: Individuals with cancer experience the impact of chemotherapy on hair loss in different ways. The aim of this pilot study was to explore patients' experiences of alopecia through patients' drawings. Methods: Fifteen female patients diagnosed with cancer and treated with chemotherapy were recruited at the oncological day-care unit of a teaching hospital in the Netherlands. Participants completed a semi-structured interview about alopecia. They drew their head and hair before and during chemotherapy and completed the Brief Illness Perception Questionnaire (B-IPQ).Results: The drawings revealed predominantly physical effects, rather than emotions. Emotions were evident in the text that patients wrote under the drawings and in the B-IPQ open question about the perceived consequences of alopecia. The overall impact of alopecia that emerged from the drawings and the B-IPQ corresponded to the information retrieved from the interviews, namely disappointment, insecurity, sadness, and confrontation.Conclusions: Drawings expose cognitive and emotional responses to alopecia that may be relatively unexplored when using traditional assessment methods such as questionnaires or interviews. In future research, the drawing instructions need to be more specifically focused on feelings in order to better capture emotional reactions to hair loss. Show less
Komen, M.M.C.; Hurk, C.J.G. van den; Nortier, J.W.R.; Ploeg, T. van der; Smorenburg, C.H.; Hoeven, J.J.M. van der 2018
Various cytotoxics cause severe alopecia, it is estimated to affect more than 15.000 Dutch cancer patients per year. Hair loss has high impact on the majority of these patients, they describe it as... Show moreVarious cytotoxics cause severe alopecia, it is estimated to affect more than 15.000 Dutch cancer patients per year. Hair loss has high impact on the majority of these patients, they describe it as stigmatizing and a constant reminder of cancer disease. Scalp cooling decreases hair loss and is well tolerated. It however induces a risk if it would protect micro-metastases in the scalp skin besides protection of hair matrix cells. In thousands of patients with solid tumors, an unfavourable development of the disease due to scalp cooling has never been reported. Furthermore, data from the Dutch Scalp Cooling Registry showed that overall 50% of the 1,411 scalp-cooled patients from 28 Dutch hospitals did not wear a head cover during their last chemotherapy session. And a randomized trial showed that the post-infusion cooling time (PICT) for 3-weekly docetaxel chemotherapy can be shortened from 90 to 45 minutes with the same effectiveness of scalp cooling. Scalp cooling is cost-effective, as is purchasing a wig or head cover. This justifies the choice between both options. Effectiveness of scalp cooling has to be and will be improved, preferably by examining optimal scalp skin temperatures and cooling times, with special attention for the patient__s tolerance. At the time of starting this PhD project, 4 Dutch hospitals applied scalp cooling, which nowadays has increased to over 75. Though, in many hospitals scalp cooling eligibility criteria are too restricted, inducing undertreatment of several patient groups. All patients facing severe alopecia should receive patient-tailored information about the possibility, effectiveness, possible side-effects and potential risk of scalp cooling in order to make an informed treatment decision Show less
