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Poster Discussion – Supportive and palliative care

3627 - Complementary Medicine (CM) Use in Phase III Clinical Trials (P3T) Conducted by the Canadian Cancer Trials Group (CCTG)

Date

28 Sep 2019

Session

Poster Discussion – Supportive and palliative care

Presenters

John Wells

Citation

Annals of Oncology (2019) 30 (suppl_5): v718-v746. 10.1093/annonc/mdz265

Authors

J.C. Wells1, A. Sidhu2, K. Ding3, D.Y.C. Heng4, F. Shepherd5, P.M. Ellis6, P.A. Bradbury5, D.J. Jonker7, M. Moore8, L.L. Siu9, K.A. Gelmon8, C. Karapetis10, J. Shapiro11, L. Nott12, C.J. O’Callaghan3, W.R. Parulekar3, L.K. Seymour13, M. Smoragiewicz3, J.G. Monzon4

Author affiliations

  • 1 Internal Medicine, Queen's University, K7L 2V7 - Kingston/CA
  • 2 Clinical Research, Fraser Health, V3T 5X3 - Surrey/CA
  • 3 Oncology, Canadian Cancer Trials Group, K7L3N6 - Kingston/CA
  • 4 Oncology, University of Calgary, Calgary/CA
  • 5 Oncology, Princess Margaret Cancer Centre, University Health Network, M5G 2C1 - Toronto/CA
  • 6 Oncology, Juravinski Hospital and Cancer Centre, L8V 5C2 - Hamilton/CA
  • 7 Department Of Medicine, Division Of Medical Oncology, Ottawa Hospital Research Institute, University of Ottawa, K1H8L6 - Ottawa/CA
  • 8 Oncology, BC Cancer Agency, V5Z 4E6 - Vancouver/CA
  • 9 Medical Oncology And Hematology Department, Princess Margaret Cancer Centre, M5G 1Z5 - Toronto/CA
  • 10 Medical Oncology, Flinders Medical Centre and Flinders University, Adelaide/AU
  • 11 Department Of Medical Oncology, Cabrini Health, 3144 - Malvern/AU
  • 12 Oncology, Royal Hobart Hospital, Tasmania/AU
  • 13 Ind Program, Canadian Cancer Trials Group, K7L 3N6 - Kingston/CA

Resources

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Abstract 3627

Background

CMs are products used concurrently with conventional medicine, including natural products and homeopathy. CM use is prevalent amongst cancer patients, but the use in patients enrolled on P3T had yet to be studied. This study examined patient characteristics and outcomes of CM users enrolled in P3T conducted by the CCTG.

Methods

Data were acquired from six international P3T and included patients with metastatic breast (BR), colorectal (CRC), and non-small-cell lung cancers (LC) (MA.31, CO.17, 20 &23, BR.21 &26). Medications were independently reviewed by two authors to identify CM; discrepancies reviewed by a third author, and the final list was approved by consensus. Patient characteristics associated with CM use were identified with Chi-square and logistic regression. Propensity score stratification was conducted to compare between CM users and non-users for overall survival (OS), grade 3+ adverse events (AE) and quality of life (QOL) scales (EORTC-QLQ-C30).

Results

3446 patients were included (17.7% BR, 44.4% CRC, 37.8% LC). Of 24908 medications, 651 (2.6%) were considered CM and 20.4% of patients were CM users. CM use in LC was associated (p < 0.05) with ECOG performance status (PS) 0-1 (vs 2+), weight loss <5%, non-smoker, and Eastern Asian ethnicity. CM use in CRC was associated with age ≤65, PS 0-1 (vs 2+), fewer sites of metastases, and normal hemoglobin. CM use in BR was only associated with age <50. CM use did not affect time to global deterioration of QoL (hazard ratio (HR) 1.07 (p = 0.22, 95%CI 0.94-1.21)). CM use HRs for OS in LC, CRC, and BC P3T were 0.80 [p = 0.005; 95% CI (0.68-0.94)], 0.87 (p = 0.08; 95% CI (0.75-1.02)), and 0.85 (p = 0.35; 95%CI (0.61-1.19)), respectively.

Conclusions

The use of CM amongst patients enrolled in P3T is high. Patient’s using CM tend to be younger and have better PS. Worse QOL indices were associated with CM use, although time to deterioration and incidence of AE were not. HR for OS in the lung cancer trials favoured CM users, however, this should be interpreted with caution given the retrospective/post-hoc nature of this study and the more favourable baseline characteristics.

Clinical trial identification

MA.31- NCT00667251 CO.17- NCT00079066 CO.20- NCT00640471 CO.23- NCT01830621 BR.21- NCT00036647 BR.26- NCT01000025.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

P.A. Bradbury: Honoraria (self), Advisory / Consultancy: AbbVie; Advisory / Consultancy: BI; Advisory / Consultancy: Merck; Honoraria (self): Lilly. C. Karapetis: Advisory / Consultancy: Merck Serono. L.K. Seymour: Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): OSI Pharmaceuticals. All other authors have declared no conflicts of interest.

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