Does palliative chemotherapy really palliate and are we measuring it correctly? A mixed methods longitudinal study of health related quality of life in advanced soft tissue sarcoma


Autoři: Nicholas Gough aff001;  Jonathan Koffman aff003;  Joy R. Ross aff004;  Julia Riley aff004;  Ian Judson aff002
Působiště autorů: Palliative Care Department, Guy’s and St Thomas’s Hospital NHS Foundation Trust, London, England, United Kingdom aff001;  The Institute of Cancer Research, London, England, United Kingdom aff002;  Kings College London, Cicely Saunders Institute, Department of Palliative Care, Policy and Rehabilitation, London, England, United Kingdom aff003;  Royal Marsden and Royal Brompton Palliative Care service, Royal Marsden NHS Foundation Trust, London, England, United Kingdom aff004;  National Heart and Lung Institute, Imperial College, London, England, United Kingdom aff005;  Sarcoma Unit, Royal Marsden NHS Foundation Trust, London, England, United Kingdom aff006
Vyšlo v časopise: PLoS ONE 14(9)
Kategorie: Research Article
doi: 10.1371/journal.pone.0210731

Souhrn

Objective

Soft tissue sarcoma (STS) is a rare cancer type that when locally advanced or metastatic, is predominantly treated with palliative chemotherapy with the aim of improving both quantity and quality of life. Given modest survival data after commencing first line chemotherapy, this study examines (i) what constitutes health related quality of life (HRQoL), (ii) whether the most commonly used HRQoL assessment tool measures this and (iii) to what extent HRQoL, and its components, change during and after treatment.

Design

Mixed-methods longitudinal study of 66 sarcoma patients living with STS (42 commencing chemotherapy, 24 under surveillance after completing chemotherapy) involving serial EORTC QLQ-C30 questionnaires and nested-qualitative semi-structured interviews with a sub-sample of participants. EORTC QLQ-C30 score change from baseline to primary evaluation point was examined using a paired t-test. Interviews were analysed using the framework approach before both datasets were integrated.

Results

Five main factors, including control of pain, were identified by study participants as important components of HRQoL; these are examined within the EORTC QLQ-C30. However, others e.g. independence loss and common causes of anxiety, are not. Whilst social and psychological domains are addressed by the EORTC QLQ-C30, the quantitative change over time did reflect qualitative descriptions of decline.

The mean overall EORTC QLQ-C30 HRQoL score deteriorated from baseline (60.4) to the primary evaluation point (50.2) [change of -10.2, t-test: -2.70, p = 0.01] for those receiving chemotherapy; this was in concordance with patients’ qualitative accounts. Baseline overall HRQoL scores were higher in the surveillance group suggesting a correlation with chemotherapy response and longer-term improvement in HRQoL. The evidence from both HRQoL scores and qualitative accounts indicated that the presence and control of physical symptoms were particularly important in maintaining HRQoL. Whilst fatigue deteriorated on chemotherapy (baseline 41.7 to 52.8; change of +11.1, t-test +2.51, p<0.05), pain (baseline 41.5 to 32.1; change -9.4, t-test -2.06 p<0.05) and sleep disturbance (43.1 to 28.5; change -14.6, t-test –3.05, p<0.05) both improved.

Conclusion

A key finding was that the EORTC QLQ-C30 assesses some but not all of the patient-reported components of HRQoL in sarcoma patients highlighting the need for either STS specific modules within the EORTC QLQ-C30 or a completely new STS specific HRQoL tool. First line palliative chemotherapy improves specific symptoms known to be prevalent and to influence HRQoL in this patient group which in some patients may translate to sustained improvement in HRQoL: further exploration and validation of these findings in larger prospective studies are warranted.

Klíčová slova:

Cancer chemotherapy – Cancer treatment – Fatigue – Chemotherapy – Patients – Quality of life – Questionnaires – Sarcomas


Zdroje

1. Network NCI (2013) Bone and Soft Tissue Sarcomas UK incidence and survival: 1996–2010 (online).

2. Sinha S, Peach AH (2010) Diagnosis and management of soft tissue sarcoma. BMJ 341: c7170. doi: 10.1136/bmj.c7170 21190968

3. Clark MA, Fisher C, Judson I, Thomas JM (2005) Soft-tissue sarcomas in adults. N Engl J Med 353: 701–711. doi: 10.1056/NEJMra041866 16107623

4. Coindre JM, Terrier P, Guillou L, Le Doussal V, Collin F, et al. (2001) Predictive value of grade for metastasis development in the main histologic types of adult soft tissue sarcomas: a study of 1240 patients from the French Federation of Cancer Centers Sarcoma Group. Cancer 91: 1914–1926. doi: 10.1002/1097-0142(20010515)91:10<1914::aid-cncr1214>3.0.co;2-3 11346874

5. (2014) Soft tissue and visceral sarcomas: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 25 Suppl 3: iii102–112.

6. Woll PJ, Reichardt P, Le Cesne A, Bonvalot S, Azzarelli A, et al. (2012) Adjuvant chemotherapy with doxorubicin, ifosfamide, and lenograstim for resected soft-tissue sarcoma (EORTC 62931): a multicentre randomised controlled trial. Lancet Oncol 13: 1045–1054. doi: 10.1016/S1470-2045(12)70346-7 22954508

7. Alessandro Gronchi SF, Vittorio Quagliuolo et al. (2017) Histotype-tailored neoadjuvant chemotherapy versus standard chemotherapy in patients with high-risk soft-tissue sarcomas (ISG-STS 1001): an international, open-label, randomised, controlled, phase 3, multicentre trial. The Lancet Oncology 18: 812–822. doi: 10.1016/S1470-2045(17)30334-0 28499583

8. Sleijfer S, Seynaeve C, Verweij J (2005) Using single-agent therapy in adult patients with advanced soft tissue sarcoma can still be considered standard care. Oncologist 10: 833–841. doi: 10.1634/theoncologist.10-10-833 16314294

9. Sleijfer S, Ouali M, van Glabbeke M, Krarup-Hansen A, Rodenhuis S, et al. (2010) Prognostic and predictive factors for outcome to first-line ifosfamide-containing chemotherapy for adult patients with advanced soft tissue sarcomas: an exploratory, retrospective analysis on large series from the European Organization for Research and Treatment of Cancer-Soft Tissue and Bone Sarcoma Group (EORTC-STBSG). Eur J Cancer 46: 72–83. doi: 10.1016/j.ejca.2009.09.022 19853437

10. Judson I, Verweij J, Gelderblom H, Hartmann JT, Schoffski P, et al. (2014) Doxorubicin alone versus intensified doxorubicin plus ifosfamide for first-line treatment of advanced or metastatic soft-tissue sarcoma: a randomised controlled phase 3 trial. Lancet Oncol 15: 415–423. doi: 10.1016/S1470-2045(14)70063-4 24618336

11. Tap WD, Jones RL, Van Tine BA, Chmielowski B, Elias AD, et al. (2016) Olaratumab and doxorubicin versus doxorubicin alone for treatment of soft-tissue sarcoma: an open-label phase 1b and randomised phase 2 trial. Lancet 388: 488–497. doi: 10.1016/S0140-6736(16)30587-6 27291997

12. Grimer R, Judson I, Peake D, Seddon B (2010) Guidelines for the management of soft tissue sarcomas. Sarcoma 2010: 506182. doi: 10.1155/2010/506182 20634933

13. Van Glabbeke M, van Oosterom AT, Oosterhuis JW, Mouridsen H, Crowther D, et al. (1999) Prognostic factors for the outcome of chemotherapy in advanced soft tissue sarcoma: an analysis of 2,185 patients treated with anthracycline-containing first-line regimens—a European Organization for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group Study. J Clin Oncol 17: 150–157. doi: 10.1200/JCO.1999.17.1.150 10458228

14. Karavasilis V, Seddon BM, Ashley S, Al-Muderis O, Fisher C, et al. (2008) Significant clinical benefit of first-line palliative chemotherapy in advanced soft-tissue sarcoma: retrospective analysis and identification of prognostic factors in 488 patients. Cancer 112: 1585–1591. doi: 10.1002/cncr.23332 18278813

15. Harris SM, M. Thway K. Al-Muderis O. Jones RL. Benson C Miah A. Judson I. (2015) Metastatic Soft Tissue sarcoma: an analysis of systemic therapy and impact on survival Journal of Clinical Oncology 33 (Supplement).

16. Van Glabbeke M, Verweij J, Judson I, Nielsen OS (2002) Progression-free rate as the principal end-point for phase II trials in soft-tissue sarcomas. Eur J Cancer 38: 543–549. doi: 10.1016/s0959-8049(01)00398-7 11872347

17. Sleijfer SJ, I. Demetri, GD (2012) How do you decide whether to offer and use "nonstandard" therapies in patients with advanced sarcomas and gastrointestinal stromal tumours: Global variations in clinical practice, assessment, and access to therapies in diseases with limited incidence and data. ASCO Educational Book.

18. Benjamin RS (1987) Grade 3 nausea, vomiting, and myelosuppression or progressive, metastatic sarcoma? J Clin Oncol 5: 833–835. doi: 10.1200/JCO.1987.5.6.833 3295127

19. Younger E, Wilson R, van der Graaf WTA, Husson O (2018) Health-Related Quality of Life in Patients With Sarcoma: Enhancing Personalized Medicine. J Clin Oncol: JCO2018779819.

20. Basch E, Abernethy AP, Mullins CD, Reeve BB, Smith ML, et al. (2012) Recommendations for incorporating patient-reported outcomes into clinical comparative effectiveness research in adult oncology. J Clin Oncol 30: 4249–4255. doi: 10.1200/JCO.2012.42.5967 23071244

21. Osoba D (2011) Health-related quality of life and cancer clinical trials. Ther Adv Med Oncol 3: 57–71. doi: 10.1177/1758834010395342 21789156

22. Fayers PMaM, D. (2007) Quality of LIfe: Wiley.

23. Organisation WH (1948.) Preamble to the Constitution of the World Health Organization as adopted by the International Health Conference, New York, 19 June—22 July 1946; signed on 22 July 1946 by the representatives of 61 States (Official Records of the World Health Organization, no. 2, p. 100) and entered into force on 7 April 1948.

24. Johnson RBAJO, A.J. Turner,L.A. (2007) Toward a Definition of Mixed Methods Research Journal of Mixed Methods Research 1.

25. Greene J (2007) Mixed methods in social enquiry. Sam Fancisco, CA: Wiley.

26. Judson I (2011) Verbal communication with the Royal Marsden Sarcoma team London

27. O’Cathain A, Murphy E, Nicholl J (2007) Why, and how, mixed methods research is undertaken in health services research in England: a mixed methods study. BMC Health Serv Res 7: 85. doi: 10.1186/1472-6963-7-85 17570838

28. Seddon B, Strauss SJ, Whelan J, Leahy M, Woll PJ, et al. (2017) Gemcitabine and docetaxel versus doxorubicin as first-line treatment in previously untreated advanced unresectable or metastatic soft-tissue sarcomas (GeDDiS): a randomised controlled phase 3 trial. Lancet Oncol 18: 1397–1410. doi: 10.1016/S1470-2045(17)30622-8 28882536

29. Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, et al. (1993) The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 85: 365–376. doi: 10.1093/jnci/85.5.365 8433390

30. Gough NJ, Smith C, Ross JR, Riley J, Judson I (2011) Symptom burden, survival and palliative care in advanced soft tissue sarcoma. Sarcoma 2011: 325189. doi: 10.1155/2011/325189 22190862

31. Preston NJ, Fayers P, Walters SJ, Pilling M, Grande GE, et al. (2013) Recommendations for managing missing data, attrition and response shift in palliative and end-of-life care research: part of the MORECare research method guidance on statistical issues. Palliat Med 27: 899–907. doi: 10.1177/0269216313486952 23652842

32. Ritchie JSL (1994) Qualitative data analysis for applied policy research. Analysis of qualitative data.; (Eds) BABR, editor. London: Routledge.

33. Sandelowski M (2001) Real qualitative researchers do not count: the use of numbers in qualitative research. Res Nurs Health 24: 230–240. 11526621

34. Scott N (2008) EORTC QLQ-C30 Reference Values Belguim: EORTC.

35. Gough N, Koffman J, Ross JR, Riley J, Judson I (2017) Symptom Burden in Advanced Soft-Tissue Sarcoma. J Pain Symptom Manage 53: 588–597. doi: 10.1016/j.jpainsymman.2016.10.357 28042077

36. Chang VT, Hwang SS, Feuerman M, Kasimis BS, Thaler HT (2000) The memorial symptom assessment scale short form (MSAS-SF). Cancer 89: 1162–1171. doi: 10.1002/1097-0142(20000901)89:5<1162::aid-cncr26>3.0.co;2-y 10964347

37. Winnette R, Hess LM, Nicol SJ, Tai DF, Copley-Merriman C (2016) The Patient Experience with Soft Tissue Sarcoma: A Systematic Review of the Literature. Patient.

38. Etkind SN, Daveson BA, Kwok W, Witt J, Bausewein C, et al. (2015) Capture, transfer, and feedback of patient-centered outcomes data in palliative care populations: does it make a difference? A systematic review. J Pain Symptom Manage 49: 611–624. doi: 10.1016/j.jpainsymman.2014.07.010 25135657

39. Velikova G, Booth L, Smith AB, Brown PM, Lynch P, et al. (2004) Measuring quality of life in routine oncology practice improves communication and patient well-being: a randomized controlled trial. J Clin Oncol 22: 714–724. doi: 10.1200/JCO.2004.06.078 14966096

40. Poveda A, Lopez-Pousa A, Martin J, Del Muro JG, Bernabe R, et al. (2005) Phase II Clinical Trial With Pegylated Liposomal Doxorubicin (CAELYX(R)/Doxil(R)) and Quality of Life Evaluation (EORTC QLQ-C30) in Adult Patients With Advanced Soft Tissue Sarcomas: A study of the Spanish Group for Research in Sarcomas (GEIS). Sarcoma 9: 127–132. doi: 10.1080/13577140500287024 18521419

41. Coens C, van der Graaf WT, Blay JY, Chawla SP, Judson I, et al. (2015) Health-related quality-of-life results from PALETTE: A randomized, double-blind, phase 3 trial of pazopanib versus placebo in patients with soft tissue sarcoma whose disease has progressed during or after prior chemotherapy-a European Organization for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group Global Network Study (EORTC 62072). Cancer.

42. Anderson H, Hopwood P, Stephens RJ, Thatcher N, Cottier B, et al. (2000) Gemcitabine plus best supportive care (BSC) vs BSC in inoperable non-small cell lung cancer—a randomized trial with quality of life as the primary outcome. UK NSCLC Gemcitabine Group. Non-Small Cell Lung Cancer. Br J Cancer 83: 447–453. doi: 10.1054/bjoc.2000.1307 10945489

43. Shepherd FA, Dancey J, Ramlau R, Mattson K, Gralla R, et al. (2000) Prospective randomized trial of docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy. J Clin Oncol 18: 2095–2103. doi: 10.1200/JCO.2000.18.10.2095 10811675

44. Crino L, Scagliotti GV, Ricci S, De Marinis F, Rinaldi M, et al. (1999) Gemcitabine and cisplatin versus mitomycin, ifosfamide, and cisplatin in advanced non-small-cell lung cancer: A randomized phase III study of the Italian Lung Cancer Project. J Clin Oncol 17: 3522–3530. doi: 10.1200/JCO.1999.17.11.3522 10550150

45. Sprangers MA, Schwartz CE (1999) Integrating response shift into health-related quality of life research: a theoretical model. Soc Sci Med 48: 1507–1515. doi: 10.1016/s0277-9536(99)00045-3 10400253

46. Grond S, Zech D, Diefenbach C, Bischoff A (1994) Prevalence and pattern of symptoms in patients with cancer pain: a prospective evaluation of 1635 cancer patients referred to a pain clinic. J Pain Symptom Manage 9: 372–382. doi: 10.1016/0885-3924(94)90174-0 7963790

47. Delgado-Guay M, Yennurajalingam S, Parsons H, Palmer JL, Bruera E (2011) Association between self-reported sleep disturbance and other symptoms in patients with advanced cancer. J Pain Symptom Manage 41: 819–827. doi: 10.1016/j.jpainsymman.2010.07.015 21306864

48. Aktas A, Walsh D, Rybicki L (2010) Symptom clusters: myth or reality? Palliat Med 24: 373–385. doi: 10.1177/0269216310367842 20507866

49. Iop A, Manfredi AM, Bonura S (2004) Fatigue in cancer patients receiving chemotherapy: an analysis of published studies. Ann Oncol 15: 712–720. doi: 10.1093/annonc/mdh102 15111337

50. Curt GA, Breitbart W, Cella D, Groopman JE, Horning SJ, et al. (2000) Impact of cancer-related fatigue on the lives of patients: new findings from the Fatigue Coalition. Oncologist 5: 353–360. doi: 10.1634/theoncologist.5-5-353 11040270

51. Lowe M, Molassiotis A (2011) A longitudinal qualitative analysis of the factors that influence patient distress within the lung cancer population. Lung Cancer 74: 344–348. doi: 10.1016/j.lungcan.2011.03.011 21511356

52. Armstrong TS (2003) Symptoms experience: a concept analysis. Oncol Nurs Forum 30: 601–606. doi: 10.1188/03.ONF.601-606 12861321

53. Peteet JRSP S P, Ross DM, Cotton V, Truesdell P and Moczynski W (1992) Emotional support for patients with cancer who are undergoing CT: semistructured interviews of patients at a cancer institute. Radiology 182: 99–102. doi: 10.1148/radiology.182.1.1727318 1727318

54. Reichardt P, Leahy M, Garcia Del Muro X, Ferrari S, Martin J, et al. (2012) Quality of Life and Utility in Patients with Metastatic Soft Tissue and Bone Sarcoma: The Sarcoma Treatment and Burden of Illness in North America and Europe (SABINE) Study. Sarcoma 2012: 740279. doi: 10.1155/2012/740279 22550425

55. Henderson M, Addington-Hall JM, Hotopf M (2005) The willingness of palliative care patients to participate in research. J Pain Symptom Manage 29: 116–118. doi: 10.1016/j.jpainsymman.2004.12.001 15733802

56. Steinhauser KE, Clipp EC, Hays JC, Olsen M, Arnold R, et al. (2006) Identifying, recruiting, and retaining seriously-ill patients and their caregivers in longitudinal research. Palliat Med 20: 745–754. doi: 10.1177/0269216306073112 17148529

57. Cannon S (1989) Social research in stressful settings: difficulties for the sociologist studying the treatment of breast cancer. Socioogy of Health and Illness 11: 62.

58. Murray SA, Sheikh A (2006) Serial interviews for patients with progressive diseases. Lancet 368: 901–902. doi: 10.1016/S0140-6736(06)69350-1 16962865

59. Quinten C, Martinelli F, Coens C, Sprangers MA, Ringash J, et al. (2014) A global analysis of multitrial data investigating quality of life and symptoms as prognostic factors for survival in different tumor sites. Cancer 120: 302–311. doi: 10.1002/cncr.28382 24127333


Článek vyšel v časopise

PLOS One


2019 Číslo 9

Nejčtenější v tomto čísle

Tomuto tématu se dále věnují…


Kurzy

Zvyšte si kvalifikaci online z pohodlí domova

Krvácení v důsledku portální hypertenze při jaterní cirhóze – od pohledu záchranné služby až po závěrečný hepato-gastroenterologický pohled
nový kurz
Autoři: PhDr. Petr Jaššo, MBA, MUDr. Hynek Fiala, Ph.D., prof. MUDr. Radan Brůha, CSc., MUDr. Tomáš Fejfar, Ph.D., MUDr. David Astapenko, Ph.D., prof. MUDr. Vladimír Černý, Ph.D.

Rozšíření možností lokální terapie atopické dermatitidy v ordinaci praktického lékaře či alergologa
Autoři: MUDr. Nina Benáková, Ph.D.

Léčba bolesti v ordinaci praktického lékaře
Autoři: MUDr. PhDr. Zdeňka Nováková, Ph.D.

Revmatoidní artritida: včas a k cíli
Autoři: MUDr. Heřman Mann

Jistoty a nástrahy antikoagulační léčby aneb kardiolog - neurolog - farmakolog - nefrolog - právník diskutují
Autoři: doc. MUDr. Štěpán Havránek, Ph.D., prof. MUDr. Roman Herzig, Ph.D., doc. MUDr. Karel Urbánek, Ph.D., prim. MUDr. Jan Vachek, MUDr. et Mgr. Jolana Těšínová, Ph.D.

Všechny kurzy
Kurzy Doporučená témata Časopisy
Přihlášení
Zapomenuté heslo

Nemáte účet?  Registrujte se

Zapomenuté heslo

Zadejte e-mailovou adresu se kterou jste vytvářel(a) účet, budou Vám na ni zaslány informace k nastavení nového hesla.