Top

Published in:

01-04-2019 | Original Article

A supportive care intervention for people with metastatic melanoma being treated with immunotherapy: a pilot study assessing feasibility, perceived benefit, and acceptability

Authors: Judith Lacey, Anna J. Lomax, Catriona McNeil, Michael Marthick, David Levy, Steven Kao, Theresa Nielsen, Haryana M. Dhillon

Published in: Supportive Care in Cancer | Issue 4/2019

Abstract

Introduction

Increasing numbers of metastatic melanoma (MM) patients are receiving immunotherapy treatment, including pembrolizumab, and the impact on their well-being is underexplored.

Objectives

To assess the feasibility of a multimodal supportive care program to MM patients being treated with pembrolizumab.

Methods

This pre-post-test feasibility cohort study recruited MM participants treated with pembrolizumab: (i) supportive care intervention with usual care and (ii) usual care. The intervention comprised comprehensive medical assessment by supportive care physician (SCP), exercise physiologist (EP), and dietitian then a tailored supportive care program. Programs included exercise, dietary advice, non-invasive complementary therapies, and psychology consultation. Outcome measures included adherence, patient-reported symptoms, anxiety and depression, and toxicity. Descriptive data are reported.

Results

We recruited 28 participants: 13 intervention and 15 control; three did not complete the study. Most were male, with median age 66 (range 42–85) years. All intervention participants completed baseline assessments with SCP, EP, and dietitian. Two missed follow-up with EP or dietitian. Symptoms most troubling at baseline were as follows: fatigue (n = 6), sleep (n = 6), general aches and pains (n = 5), and memory (n = 4). All intervention participants were prescribed 16 exercise sessions; 8 (50%) completed all; overall exercise adherence was 85%. Integrative therapies were accessed by 85% (11) participants. Immunotherapy-related adverse event rates were low and SCP consultation identified symptoms not captured by CTCAE 4.0.

Conclusions

A holistic supportive care intervention tailored to individual needs is feasible. The symptom burden in MM patients was low. Further investigation of the intervention is warranted, focused on populations with higher symptom burden to improve outcomes.

Available only for authorised users

Australian Cancer Incidence and Mortality (ACIM) (2017) Melanoma of the Skin for Australia (ICD10 C43). Available from: http://www.aihw.gov.au/acim-books

Mahoney KM, Freeman GJ, McDermott DF (2015) The next immune-checkpoint inhibitors: PD-1/PD-L1 blockade in melanoma. Clin Ther 37(4):764–782CrossRefPubMedPubMedCentral

Robert C, Schachter J, Long G, Arance A, Grob J, Mortier L et al (2015) Pembrolizumab versus ipilimumab in advanced melanoma. N Engl J Med 372(26):2521–2532CrossRefPubMed

Schachter J, Ribas A, Long GV, Arance A, Grob JJ, Mortier L, Daud A, Carlino MS, McNeil C, Lotem M, Larkin J, Lorigan P, Neyns B, Blank C, Petrella TM, Hamid O, Zhou H, Ebbinghaus S, Ibrahim N, Robert C (2017) Pembrolizumab versus ipilimumab for advanced melanoma: final overall survival results of a multicentre, randomised, open-label phase 3 study (KEYNOTE-006). Lancet 390(10105):1853–1862CrossRefPubMed

Pharmaceutical Benefits Advisory Committee (2018) Schedule of pharmaceutical benefits. In: Health Do (ed) Commonwealth of Australia, Canberra, Australia

O’Connor JM, Fessele KL, Steiner J, Seidl-Rathkopf K, Carson KR, Nussbaum NC, Yin ES, Adelson KB, Presley CJ, Chiang AC, Ross JS, Abernethy AP, Gross CP (2018) Speed of adoption of immune checkpoint inhibitors of programmed cell death 1 protein and comparison of patient ages in clinical practice vs pivotal clinical trials. JAMA Oncol 4:e180798CrossRefPubMedPubMedCentral

van Eeden R, Rapoport BL (2016) Supportive care of patients undergoing immunotherapy. Eur Oncol Haematol 12(1):25–27CrossRef

Harrison JD, Young JM, Price MA, Butow PN, Solomon MJ (2009) What are the unmet supportive care needs of people with cancer? A systematic review. Support Care Cancer 17(8):1117–1128CrossRefPubMed

Dhillon HM, Bell ML, van der Ploeg HP, Turner JD, Kabourakis M, Spencer L, Lewis C, Hui R, Blinman P, Clarke SJ, Boyer MJ, Vardy JL (2017) Impact of physical activity on fatigue and quality of life in people with advanced lung cancer: a randomized controlled trial. Ann Oncol 28(8):1889–1897CrossRefPubMed

10.

Cramp F, Byron-Daniel J (2012) Exercise for the management of cancer-related fatigue in adults. Cochrane Database Syst Rev 11(11):CD006145PubMed

11.

Mishra SI, Scherer RW, Snyder C, Geigle PM, Berlanstein DR, Topaloglu O (2012) Exercise interventions on health-related quality of life for people with cancer during active treatment. Cochrane Database Syst Rev 8(8):CD008465

12.

Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ (2010) Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med 363(8):733–742CrossRefPubMed

13.

Carey M, Lambert S, Smits R, Paul C, Sanson-Fisher R, Clinton-McHarg T (2012) The unfulfilled promise: a systematic review of interventions to reduce the unmet supportive care needs of cancer patients. Support Care Cancer 20(2):207–219CrossRefPubMed

14.

Berger AM, Mooney K, Alvarez-Perez A, Breitbart WS, Carpenter KM, Cella D, Cleeland C, Dotan E, Eisenberger MA, Escalante CP, Jacobsen PB, Jankowski C, LeBlanc T, Ligibel JA, Loggers ET, Mandrell B, Murphy BA, Palesh O, Pirl WF, Plaxe SC, Riba MB, Rugo HS, Salvador C, Wagner LI, Wagner-Johnston ND, Zachariah FJ, Bergman MA, Smith C (2015) Cancer-related fatigue, version 2.2015. J Natl Compr Cancer Netw 13(8):1012–1039CrossRef

15.

Khoja L, Butler MO, Kang SP, Ebbinghaus S, Joshua AM (2015) Pembrolizumab. J Immunother Cancer 3(1):36CrossRefPubMedPubMedCentral

16.

Bower JE, Bak K, Berger A, Breitbart W, Escalante CP, Ganz PA, Schnipper HH, Lacchetti C, Ligibel JA, Lyman GH, Ogaily MS, Pirl WF, Jacobsen PB (2014) Screening, assessment, and management of fatigue in adult survivors of cancer: an American Society of Clinical Oncology clinical practice guideline adaptation. J Clin Oncol 32(17):1840–U127CrossRefPubMedPubMedCentral

17.

Lopez G, Mao J, Cohen L (2017) Integrative oncology. Med Clin N Am 101(5):977–985CrossRefPubMed

18.

Grant S, Marthick M, Lacey J (2018) Establishing an integrative oncology service in the Australian healthcare setting—the Chris O’Brien Lifehouse Hospital experience. Supportive Care in Cancer. (published online)

19.

Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J (1993) The functional assessment of cancer therapy scale: development and validation of the general measure. J Clin Oncol 11(3):570–579CrossRefPubMed

20.

Hui DB, Eduardo (2016) The Edmonton symptom assessment system 25 years later: past, present, and future developments. J Pain Symptom Manag 53(3):630–643CrossRef

21.

Zigmond AS, Snaith RP (1983) The hospital anxiety and depression scale. Acta Psychiatr Scand 67(6):361–370CrossRefPubMed

22.

Read JA, Crockett N, Volker DH, MacLennan P, Choy STB, Beale P, Clarke SJ (2005) Nutritional assessment in Cancer: comparing the Mini-Nutritional Assessment (MNA) with the scored Patient-Generated Subjective Global Assessment (PGSGA). Nutr Cancer 53(1):51–56CrossRefPubMed

23.

Institute NC (2010) Common terminology criteria for adverse events (CTCAE). In: Services UDoHaH (ed) NIH

24.

Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J (2009) New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 45(2):228–247CrossRefPubMed

25.

Janda M, DiSipio T, Hurst C, Cella D, Newman B (2009) The Queensland Cancer Risk Study: general population norms for the Functional Assessment of cancer Therapy-General (FACT-G). Psychooncology 18(6):606–614CrossRefPubMed

26.

Office QoL (2018) Calculating nom-based T-scores from your FACT-G data. POCOG, University of Sydney, Sydney Available from: www.pocog.org.au/pod/factgscores.aspx

27.

Eigentler TK, Hassel JC, Berking C, Aberle J, Bachmann O, Grünwald V, Kähler KC, Loquai C, Reinmuth N, Steins M, Zimmer L, Sendl A, Gutzmer R (2016) Diagnosis, monitoring and management of immune-related adverse drug reactions of anti-PD-1 antibody therapy. Cancer Treat Rev 45:7–18CrossRefPubMed

28.

Kotronoulas G, Kearney N, Maguire R, Harrow A, Di Domenico D, Croy S et al (2014) What is the value of the routine use of patient-reported outcome measures toward improvement of patient outcomes, processes of care, and health service outcomes in cancer care? A systematic review of controlled trials. Journal of Clinical Oncology 32(14):1480CrossRefPubMed

29.

Kotronoulas G, Papadopoulou C, MacNicol L, Simpson M, Maguire R (2017) Feasibility and acceptability of the use of patient-reported outcome measures (PROMs) in the delivery of nurse-led supportive care to people with colorectal cancer. Eur J Oncol Nurs 29:115–124CrossRefPubMed

30.

Polley M, Seers J, Cooke HJ, Hoffman C, Paterson C (2007) How to summarise and report written qualitative data from patients: a method for use in cancer support care. Support Care Cancer 15(8):963–971CrossRefPubMed

31.

Ben-Arye E, Dahly H, Keshet Y, Dagash J, Samuels N (2018 Sep) Providing integrative care in the pre-chemotherapy setting: a pragmatic controlled patient-centered trial with implications for supportive cancer care. J Cancer Res Clin Oncol 144(9):1825–1833CrossRefPubMed

32.

Solomon H, Brown C, Vennettilli A, Zarrin A, Dobriyal A, Chen L et al (2014) Involving patients to improve their care through real-time patient reported outcome (PRO)-CTCAE chemotoxicity surveys in an outpatient chemodaycare (DC) setting: evaluating patient acceptability. Journal of Clinical Oncology 32(30_suppl):64CrossRef

33.

Grimmett C, Haviland J, Winter J, Calman L, Din A, Richardson A, et al (2017) Colorectal cancer patient's self-efficacy for managing illness-related problems in the first 2 years after diagnosis, results from the ColoREctal Well-being (CREW) study. J Cancer Surviv

34.

Lobb E, Lacey J, Kearsley J, Liauw W, White L, Hosie A (2015) Living with advanced cancer and an uncertain disease trajectory: an emerging patient population in palliative care? BMJ Support Palliat Care 5(4):352–357CrossRefPubMed

35.

Serfaty M, Wilkinson S, Freeman C, Mannix K, King M (2012) The ToT Study: helping with Touch or Talk (ToT): a pilot randomised controlled trial to examine the clinical effectiveness of aromatherapy massage versus cognitive behaviour therapy for emotional distress in patients in cancer/palliative care. Psycho-Oncology 21(5):563–569CrossRefPubMed

36.

Dieng M, Kasparian NA, Morton RL, Mann GJ, Butow PN, Menzies S et al (2015) The Melanoma Care Study: protocol of a randomised controlled trial of a psycho-educational intervention for melanoma survivors at high risk of developing new primary disease. BMC Psychology 3(23):13

37.

Levy D, Dhillon HM, Lomax A, Marthick M, McNeil C, Kao S, Lacey J (2018) Certainty within uncertainty: a qualitative study of the experience of metastatic melanoma patients undergoing pembrolizumab immunotherapy. Support Care Cancer

38.

Wolchok JD, Chiarion-Sileni V, Gonzalez R, Rutkowski P, Grob JJ, Cowey CL, Lao CD, Wagstaff J, Schadendorf D, Ferrucci PF, Smylie M, Dummer R, Hill A, Hogg D, Haanen J, Carlino MS, Bechter O, Maio M, Marquez-Rodas I, Guidoboni M, McArthur G, Lebbé C, Ascierto PA, Long GV, Cebon J, Sosman J, Postow MA, Callahan MK, Walker D, Rollin L, Bhore R, Hodi FS, Larkin J (2017) Overall survival with combined nivolumab and ipilimumab in advanced melanoma. N Engl J Med 377(14):1345–1356CrossRefPubMedPubMedCentral

39.

Schadendorf D, Larkin J, Wolchok J, Hodi FS, Chiarion-Sileni V, Gonzalez R, Rutkowski P, Grob JJ, Cowey CL, Lao C, Wagstaff J, Callahan MK, Postow MA, Smylie M, Ferrucci PF, Dummer R, Hill A, Taylor F, Sabater J, Walker D, Kotapati S, Abernethy A, Long GV (2017) Health-related quality of life results from the phase III CheckMate 067 study. Eur J Cancer 82:80–91CrossRefPubMedPubMedCentral

Title: A supportive care intervention for people with metastatic melanoma being treated with immunotherapy: a pilot study assessing feasibility, perceived benefit, and acceptability
Authors: Judith Lacey
Anna J. Lomax
Catriona McNeil
Michael Marthick
David Levy
Steven Kao
Theresa Nielsen
Haryana M. Dhillon
Publication date: 01-04-2019
Publisher: Springer Berlin Heidelberg
Published in: Supportive Care in Cancer / Issue 4/2019
Print ISSN: 0941-4355
Electronic ISSN: 1433-7339
DOI: https://doi.org/10.1007/s00520-018-4524-3

Webinar | 19-02-2024 | 17:30 (CET)

Keynote webinar | Spotlight on antibody–drug conjugates in cancer

Watch now

Antibody–drug conjugates (ADCs) are novel agents that have shown promise across multiple tumor types. Explore the current landscape of ADCs in breast and lung cancer with our experts, and gain insights into the mechanism of action, key clinical trials data, existing challenges, and future directions.

Dr. Véronique Diéras

Prof. Fabrice Barlesi

Developed by: Springer Medicine

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Introduction

Objectives

Methods

Results

Conclusions

Please log in to get access to this content

Other articles of this Issue 4/2019

Relationship between skeletal muscle function, body composition, and weight loss in patients with advanced pancreatic and gastrointestinal cancers

Feasibility of using a pragmatic trials model to compare two primary febrile neutropenia prophylaxis regimens (ciprofloxacin versus G-CSF) in patients receiving docetaxel-cyclophosphamide chemotherapy for breast cancer (REaCT-TC)

Cancer survivorship care after curative treatment: Chinese oncology practitioners’ practices

Correction to: Influence of cancer and acute inflammatory disease on taste perception: a clinical pilot study

Breast Cancer Collaborative Registry informs understanding of factors predicting sleep quality

The effect of vitamin D and E vaginal suppositories on tamoxifen-induced vaginal atrophy in women with breast cancer

Keynote webinar | Spotlight on antibody–drug conjugates in cancer