Preventive Rehabilitation In Advanced Chemo-radiated H&N Cancer Patients; 2-year results and dose-effect relationships

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1 ASHA, Nov 2012 Preventive Rehabilitation In Advanced Chemo-radiated H&N Cancer Patients; 2-year results and dose-effect relationships Lisette van der Molen PhD SLP 1, Maya A van Rossum PhD, Ludi E Smeele, PhD MD, Coen RN Rasch PhD MD, Frans JM Hilgers PhD MD 1 Coordinator HN rehabilitation program Netherlands Cancer Institute Antoni van Leeuwenhoek hospital (NKI-AVL), Amsterdam, The Netherlands

2 Disclosure Part of the study is supported by an unrestricted research grant from Atos Medical, Hörby, Sweden.

3 Background Concurrent chemo-radiotherapy (CCRT) for advanced head & neck (HN) cancer results in substantial functional problems. - primary focus on limiting doses by IMRT* Preventive exercises are postulated to reduce short-term dysphagia/trismus.** Limited data on preventive and long-term effects*** * Van der Molen et al. (2009), Roe et al. (2010), Keereweer et al. (2011), Cartmill et al. (2012) ** Van der Molen et al. (2011), Carroll et al. (2008) Kulbersh et al. (2006) *** Van der Molen et al. (submitted), Roe et al. (2011), Carnaby-Mann et al. (2012), Kotz et al. (2012)

4 Negative side-effects CCRT* Mucositis Xerostomia Fibrosis Oedema Pain Viscous saliva Taste changes Hearing loss.. Quality of life * Murry et al. (1998)/ Gaziano et al. (2002)/ Rankin et al. (2000)

5 Purpose Assess the long-term dose effects (2yrs post-treatment) of preventive rehabilitation on i.e. swallowing and mouth opening after CC(im)RT for advanced HN cancer. Differences between 2 exercise arms

6 Feasibility & Compliance Methods

7 In- and exclusion criteria Inclusion Squamous cell carcinoma Oral cavity, oropharynx, hypopharynx, larynx and nasopharynx tumors Exclusion Unable to comprehend the function and use of the rehabilitation exercises and device (e.g. Alzheimer s disease, Korsakov s disease) Physically unfit to use a rehabilitation device (e.g. neurological deficit). Stage III-IV Primary treatment with CCRT with curative intent Written informed consent

8 Methods Chemo (Cisplatinum) + IMRT (35x2 Gy) in 7 wks Preventive rehabilitation (randomisation in 2 exercise groups) Dutch guideliness; NO control group Follow-up: Chemo + IMRT Follow-up pre-ccrt N=55 10 wks N=49 26 wks 1 year N=37 2 years N=29

9 Dosimetric data Missing dosimetric data of N=1 IMRT + Chemo Follow-up pre-ccrt 10 wks N = wks 1 year N = 36 2 years N=29 Dual structures (e.g. temporalis muscle): structure with highest mean dose evaluated Evaluated: Mean Max V20-V40-V60

10 Methode RT-dose relationships IMRT with Pinnacle treatment planning system (Philips, NL) 95% of the Planning Target Volume (PTV) had to receive 95% of the prescribed dose The maximum dose allowed to the spinal cord was 50 Gy

11 Preventive exercises Practice 3 times/day; before, during, and after CCRT

12 Consort flow diagram

Patient characteristics Characteristic Baseline N=55 10 wks post N=49 1yr post N=37 2yr post N=29 M/F 44/11 39/10 28/9 23 / 6 Age (range) 58.0 (32-79) 57.0 (32-78) 58.0 (39-77) 60.

13 Patient characteristics Characteristic Baseline N=55 10 wks post N=49 1yr post N=37 2yr post N=29 M/F 44/11 39/10 28/9 23 / 6 Age (range) 58.0 (32-79) 57.0 (32-78) 58.0 (39-77) 60.0 (39-77) Nasopharynx Oral cavity/oropharynx Hypopharynx/larynx 7 (13%) 29 (53%) 19 (35%) 7 (14%) 24 (49%) 18 (37%) 6 (16%) 16 (43%) 15 (41%) 5 (17 %) 14 (48 %) 10 (35 %) Stage III Stage IV 17 (31%) 38 (69%) 16(33%) 33 (67%) 14 (38%) 23 (62%) 11 (38 %) 18 (62 %) T1 T2 T3 T4 8 (15%) 15 (27%) 21 (38%) 11 (20%) 8 (8%) 15 (31%) 19 (39%) 7 (14%) 7 (19%) 12 (32%) 14 (38%) 4 (11%) 6 (21%) 9 (32%) 11 (38%) 3 (10%) N0 N1 N2 N3 6 (11%) 15 (27%) 28 (51%) 6 (11%) 4 (8%) 14 (29%) 26 (53%) 5 (10%) 3 (8%) 13 (35%) 16 (43%) 5 (14%) 3 (10%) 10 (35%) 11 (38%) 5 (17%)

14 Videofluoroscopy PAS* Contrast residue score (score 0: no residue; score 3 residue above and below the valleculae) Mouth opening Weight (BMI) FOIS (score 1: nothing by mouth; score 7: total oral diet with no restrictions) Pain (VAS) Study specific questionnaire * Rosenbek e.a Assessment protocol

20% intra- and inter-reliability Maximum interincisor mouth Opening

15 Measurements Videofluoroscopy Swallowing twice: 1 and 5 cc thin liquid; 3cc paste; solid. Review in real-time, slow motion, and frame-by-frame. 20% intra- and inter-reliability Maximum interincisor mouth Opening (MIO) Range of motion scale Trismus = mouth opening 35 mm* *Dijkstra et al, 2006

16 Statistical analyses IBM SPSS for Windows (release 20.0, IBM Corp.) Inter and intra-observer reliability: Cronbach s Alpha Nominal variables associations: Fishers Exact Ordinal variables: Wilcoxon rank sum/ Jonckheere Terpstra Continuous variables (compared by means): Wilcoxon rank sum Predictive value of dose parameters for the measured endpoints: Binary logistic regression model For all analyses: P-value of.05

17 Results overall Residue measured by videofluoroscopy p=0.032*

18 Results overall (2) Measurements mouth opening/ oral intake

19 Results: dysphagia Objective At 10-weeks post-treatment: - 8/39 (21%) with swallowing problems. - Sign. predictor of PAS is mean dose and V60 to the IC (p=.05/p=.05) Variation in mean dose SC and MC is limited (~40-70 Gy) At 2-year post-treatment: - 4/29 (14%) with swallowing problems - No sign. correlations

20 Results: swallowing problems Subjective At 10-weeks post-treatment: - 14/40 pts (35%) with swallowing problems (solid food) - Significant predictor dose-volume V60 to the IC (p=.05) and mean dose to the masseter muscle (p=.05) correlation with the studied dose parameters

21 Results: swallowing problems (2) Subjective At 1-year post-treatment: - 15/29 (52%) with swallowing problems (solid food) - No sign. correlation with swallowing structures, but sign. predictor of PAS is the mean dose, dosevolumes V20/V40/V60 to the Masseter (all p>.05)

22 Results: trismus Objective At 10-weeks post-treatment: - 6/44 (14%) trismus - Sign. predictors of trismus were the mean dose and dose-volumes V20/V40 to the Masseter (all p>.05), and Pterygoids (all p>.050) At 2-year post-treatment: - 2/29 (7%) trismus - Too few events for analyses

23 Subjective Results: mouth opening At 10-weeks post-treatment: - 9/47 (19%) experienced a decreased MMO - Sign. predictor of decreased MMO was dose-volume V40 to the Masseter (p=.035) At 2-year post-treatment: - 6/29 (21%) experienced a decreased MMO - Sign. predictors were mean dose, max dose, and V20/V40/V60 to the Masseter, and Pterygoids (all p>.05) and max dose and dose-volume V20 to the mandibular condyle (p>.05) and max dose to the temporalis (p>.05)

25 Conclusions Minimal functional problems after 2-years (no significant differences between preventive exercise groups, despite contrast residue) Dysphagia associated with dose to Inferior Constrictor and MMO/trismus associated with dose to the jaw structures Comparable with the literature* Transfer to standard clinical practice: delineated the studied structures! *Teguh et al, 2008, Feng et al, 2007, Eisbruch et al, 2007, Levendag et al. 2007

26 Discussion Weakness of the study: no control group Comparable results are found in the literature related to short-term results, and dose-effects, but long-term results are still scarce Transfer clinical practice: Multidisciplinairy Head and Neck rehabilitation program Cost-effective study; Retel e.a., BMC Cancer 2011

27 QUESTIONS?

28 THANK YOU FOR YOUR ATTENTION Upcoming course NKI-AVL

UvA-DARE (Digital Academic Repository)

UvA-DARE (Digital Academic Repository) Dysphagia and trismus after concomitant chemo-intensity-modulated Radiation Therapy (chemo-imrt) in advanced head and neck cancer; dose-effect relationships for swallowing