ESMO Supporter 2018

Displaying One Session

Hall B3 - Room 20 Proffered Paper session
Date
21.10.2018
Time
14:45 - 16:15
Location
Hall B3 - Room 20
Chairs
  • Karin Jordan (Heidelberg, DE)
  • Jorn Herrstedt (Roskilde, DK)
Proffered paper session - Supportive and palliative care Proffered Paper session

Session DOI

Lecture Time
14:45 - 14:45
Location
Hall B3 - Room 20, ICM München, Munich, Germany
Date
21.10.2018
Time
14:45 - 16:15
Proffered paper session - Supportive and palliative care Proffered Paper session

1681O - Evaluation of practice patterns for prevention of chemotherapy (CT)-induced nausea and vomiting (CINV) and antiemetic guidelines (GLs) adherence based on real-world prescribing data

Presentation Number
1681O
Lecture Time
14:45 - 14:57
Speakers
  • Matti S. Aapro (Genolier, CH)
Location
Hall B3 - Room 20, ICM München, Munich, Germany
Date
21.10.2018
Time
14:45 - 16:15

Abstract

Background

GLs-recommended antiemetic treatment improves emesis in most patients (pts) receiving CT. Non-adherence to GLs leads to suboptimal CINV control. MASCC/ESMO GLs recommend prophylaxis with a neurokinin-1 receptor antagonist (NK1RA), a 5-hydroxytryptamine-3 (5-HT3) RA, and dexamethasone (DEX) for pts receiving highly emetogenic CT (HEC, including anthracycline-cyclophosphamide [AC]) and carboplatin-based regimens. Here, we analyse use of NK1RA + 5-HT3RA + DEX for antiemetic prophylaxis prior to HEC and carboplatin (considered moderately EC [MEC]).

Methods

The data source was the Global Oncology Monitor (Ipsos Healthcare). Geographically representative physicians from France, Germany, Italy, Spain, and UK were screened for treatment involvement and number of pts treated/month. Pts’ data from Jan–Dec 2017 were collected and extrapolated based on a doctor universe; projected estimates are shown here. The emetic risk of CT was classified per MASCC/ESMO GLs.

Results

Antiemetic treatment use is shown (Table). Data from 46,503 pts treated with CT were collected, which represents a total prevalence of 1,468,522 CT-treated pts included in the analysis. NK1RAs were used in 39%/36%/23% of pts receiving cisplatin-/AC-/carboplatin-based CT, respectively; 18%/20%/11% received the GLs-recommended NK1RA + 5-HT3RA + DEX combination; 17% of all HEC-/MEC-treated pts received no antiemetics. Physicians’ perception of the emetic risk of CT did not follow MASCC/ESMO GLs classification for 48%/48%/43% of cisplatin-/AC-/carboplatin-based regimens.

Use of NK1RA-based prophylactic antiemetic treatments for CINV by emetic risk of chemotherapy according to the MASCC/ESMO guidelines classification

Chemotherapy regimenTotal patients,* %, nPatients with NK1RAs,* %, nNK1RA + 5-HT3 RA + DEX, %NK1RA  + 5-HT3RA, %NK1RA + DEX, %NK1RA monotherapy, %NK1RA + other antiemetics, %
HEC – cisplatin based55% of HEC 211,60039% 81,82718% 38,80416% 33,3632% 4,9352% 4,5540% 172
HEC – AC based39% of HEC 151,18536% 54,72420% 30,95512% 18,6012% 3,4971% 1,4190% 252
HEC – other6% of HEC 22,21917% 3,8032% 51513% 2,8941% 1441% 2340% 15
MEC – carboplatin based30% of MEC 177,02723%, 40,31711% 18,83910% 17,4841% 1,9951% 1,6560% 343
Total (all HEC + carboplatin based)38% of all patients 562,03232% 180,67116% 89,11413% 72,3422% 10,5711% 7,8620% 783

5-HT3RA, 5-hydroxytryptamine-3 receptor antagonist; AC, anthracycline-cyclophosphamide; CINV, chemotherapy-induced nausea and vomiting; DEX, dexamethasone; HEC, highly emetogenic chemotherapy; MASCC/ESMO, Multinational Association of Supportive Care in Cancer/European Society for Medical Oncology; MEC, moderately emetogenic chemotherapy; NK1RA, neurokinin-1 receptor antagonist.

Estimate of total number of patients is based on the projected prevalence of total 1,468,522 patients being treated with chemotherapy. A sample of 46,503 patients was used for the projections.

Conclusions

EU practice patterns revealed very low adherence to antiemetic GLs in clinical practice, with 16% of all pts (HEC/AC/carboplatin) receiving an NK1RA + 5-HT3RA + DEX, and 17% of HEC-/MEC-treated pts receiving no antiemetics. New strategies to improve GLs adherence are critically needed.

Legal entity responsible for the study

Helsinn Healthcare.

Funding

Helsinn Healthcare.

Editorial Acknowledgement

Editorial and medical writing support was provided by Iratxe Abarrategui, PhD, CMPP, from TRM Oncology, The Hague, The Netherlands, and funded by Helsinn.

Disclosure

M.S. Aapro: Advisor, honoraria: Eisai, Helsinn, Merck, Mundipharma, Tesaro; Research grants: Helsinn, Merck, Tesaro. F. Scotté: Member of advisory boards or speaker: Roche, Amgen, Tesaro, Vifor, MSD, Pierre Fabre Oncology, Leo Pharma, Sanofi, Helsinn, Pfizer. L. Celio: Advisor: Italfarmaco SpA. R.D. Berman: Honoraria for seminars and lectures: Chugai, Tesaro. A. Franceschetti, D. Bell: Employee: Ipsos. K. Jordan: Consultant or received honoraria: Helsinn Healthcare, Tesaro, Merck/MSD. All other authors have declared no conflicts of interest.

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Proffered paper session - Supportive and palliative care Proffered Paper session

1682O_PR - Final results of a phase II/III, randomized, double blind, placebo-controlled study to investigate the efficacy of a high potency multistrain probiotic, on chemotherapy induced diarrhea in cancer patients receiving fluropyrimidines and/or irinotecan based therapy

Presentation Number
1682O_PR
Lecture Time
14:57 - 15:09
Speakers
  • Atul Sharma (new delhi, IN)
Location
Hall B3 - Room 20, ICM München, Munich, Germany
Date
21.10.2018
Time
14:45 - 16:15

Abstract

Background

Chemotherapy-induced diarrhea (CID) is a common side-effect, associated with weight-loss, malnutrition, and treatment breaks. Chemotherapy changes the composition of the native gut microflora. We hypothesized that a high-concentration multi-strain probiotic product might improve the balance of intestinal flora and thus reduce the incidence of severe diarrheal grades.

Methods

Randomized, double-blind, placebo-controlled single center study. Total sample size calculated was 242, however, protocol was amended to enrol 291 patients, accounting for loss to follow up or protocol deviations. Primary end-point was incidence of grade 3 and grade 4 diarrhea. Analysis of serum VEGF & clusterin and fecal calprotectin was also planned. Regulatory approvals and trial registration were done before study initiation.

Enrolled patients were randomized to receive 1 sachet bid of study drug (900 billion CFU/sachet of 4 strains of Lactobacillus, 3 strains of Bifidobacteria and 1 strain of Streptococcus thermophilus) or placebo (corn starch), starting 14 days before chemotherapy and continued till two weeks after end of chemotherapy cycle 3.

Results

Between July 2010 to November 2014, 291 patients were enrolled at AIIMS, New Delhi. Type and site of cancer (p=0.882) and chemotherapy regimen (p=0.492) were similar in both groups. Body weight between the two arms was found to be comparable at all study visits. Results are shown in Table-1.

Table -1

Variables

Drug

Placebo

P value

DEMOGRAPHY

Total (N)

145

146

NS

Male [N(%)]

113 (77.9)

123 (84.2)

0.160*

Age in years (Mean ± SD)

46.4 ± 11.8

45.6 ± 12.1

0.615^

ENDPOINTS ASSESSMENTS

Incidence of all diarrheal grades (N)

199

220

0.019*

Grade III [N(%)]

16 (8.0)

9 (4.1)

0.088*

Grade IV [N(%)]

4 (2)

0 (0)

0.050#

Rescue medication [N(%)]

15 (5.5)

20 (6.2)

0.440*

INFLAMMATORY AND OTHER MARKERS ASSESSMENTS@ at study end

VEGF

829.5 ± 345.0

1416.91 ± 379.9

< 0.001**

Calprotectin

485.1 ± 117.2

617.40 ± 140.1

< 0.001**

Clusterin

102.4 ± 38.0

145.86 ± 31.5

< 0.001**

* Pearson chi-square test

^ T-test

# Fisher’s Exact test

** Mann-Whitney Test

@ Comparable at baseline

Conclusions

Results indicate a limited role of the probiotic in reducing incidence of severe CID. However, it was able to significantly reduce all grades of diarrheal episodes (taken together), levels of VEGF, fecal calprotectin and clusterin.

Clinical trial identification

Clinical Trial Registry India Identifier : CTRI/2009/091/001042

Editorial Acknowledgement

Not Applicable

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Proffered paper session - Supportive and palliative care Proffered Paper session

Invited Discussant 1681O and 1682O

Lecture Time
15:09 - 15:24
Speakers
  • Jorn Herrstedt (Roskilde, DK)
Location
Hall B3 - Room 20, ICM München, Munich, Germany
Date
21.10.2018
Time
14:45 - 16:15
Proffered paper session - Supportive and palliative care Proffered Paper session

1511O - Training oncologists and preparing patients for shared decision making about palliative systemic treatment: results from the randomized controlled CHOICE study

Presentation Number
1511O
Lecture Time
15:24 - 15:36
Speakers
  • Hanneke W. Van Laarhoven (Amsterdam, NL)
Location
Hall B3 - Room 20, ICM München, Munich, Germany
Date
21.10.2018
Time
14:45 - 16:15

Abstract

Background

Systematic treatment for advanced cancer offers uncertain and often limited benefits whilst the burden can be high. Hence, treatment decisions require Shared Decision Making (SDM). We examined the separate and combined effect of oncologist training and a patient communication aid on SDM in consultations about palliative systemic treatment.

Methods

A multi-center RCT with four parallel arms was conducted (NTR 5489). To attain a power of 80%, we included 31 medical oncologists and 194 of their patients with advanced cancer with a median life expectancy of < 12 months. Oncologists were randomized to receive training or not; patients were randomized to receive a patient communication aid or not. The oncologist training consisted of a reader, two group sessions, a booster feedback session and a consultation room tool. The patient communication aid consisted of a question prompt list and a value clarification exercise. Either an initial consultation about the start of systemic treatment or an evaluative consultation about (dis)continuation was audio-recorded for each patient. The primary outcome was observed SDM (OPTION12), rated by blinded assessors. Intervention effects were investigated with multilevel analysis.

Results

Audio-recorded consultations of 187 patients and 27 oncologists were available for analysis. The oncologist training had a large effect on observed SDM among patients who did not receive a communication aid (d = 1.4). The patient communication aid did not have an effect on SDM among untrained oncologists (d = 0.03). The effect of the combination of training and communication aid did not exceed the single effect of training (Mtraining_aid=49.83; Mtraining_no aid=49.49; Mno training_aid=29.88; Mno training_no aid=29.50).

Conclusions

Training medical oncologists in SDM about palliative systemic treatment improved observed SDM in clinical encounters. A patient communication aid preparing patients for SDM did not add to that effect. Additional analysis should examine the effects of both interventions on secondary outcomes, such as patient satisfaction and treatment decisions.

Clinical trial identification

Netherlands Trial Registry 5489 (prospective, Sep 15 2015).

Legal entity responsible for the study

Department of Medical Psychology, Academic Medical Center, Amsterdam.

Funding

Dutch Cancer Society.

Disclosure

H.W.M. van Laarhoven: Consultant or advisory role: BMS, Lilly and Nordic Pharma; Research funding: Bayer, BMS, Celgene, Janssen, Lilly, Nordic Pharma, Philips, Roche. F.Y.F.L. De Vos: Research funding: Novartis, AbbVie en BioClin. All other authors have declared no conflicts of interest.

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Proffered paper session - Supportive and palliative care Proffered Paper session

1512O - Automated Survival Prediction in Metastatic Cancer Patients Using High-Dimensional Electronic Medical Record Data

Presentation Number
1512O
Lecture Time
15:36 - 15:48
Speakers
  • Michael F. Gensheimer (Stanford, US)
Location
Hall B3 - Room 20, ICM München, Munich, Germany
Date
21.10.2018
Time
14:45 - 16:15

Abstract

Background

Oncologists use patients’ life expectancy to guide medical decisions and may benefit from a tool that provides accurate, unbiased assessments of prognosis. Existing prognostic models generally use only a few predictor variables. We used a large electronic medical record dataset to train a prognostic model for patients with metastatic cancer.

Methods

The model was trained and tested using data from 12,588 patients treated for metastatic cancer in the Stanford Health Care system from 2008-2017. Data sources included provider note text, labs, vital signs, procedures, medication orders, and diagnosis codes. Patients were divided randomly into training and test sets (80%/20% split). A regularized Cox proportional hazards model with 4,126 predictor variables was fit to the training set and evaluated on the test set. A landmarking approach was used due to the multiple observations per patient, with t0 set to the time of metastatic cancer diagnosis. Performance was also evaluated using 399 palliative radiation courses in test set patients. An existing published model that uses performance status, primary tumor site, and treated site was used as a baseline [Chow, JCO 2008:20;26(36)].

Results

From the first visit after metastatic cancer diagnosis, median follow-up was 14.5 months and median overall survival was 20.9 months. Patients were seen for 384,402 daily visits. The prognostic model’s C-index for overall survival was 0.79 in the test set (averaged across landmark times). For palliative radiation courses, the C-index was 0.75 (95% CI 0.72-0.78), compared to 0.64 (95% CI 0.60-0.67) for an existing published model (p < 0.001).

Predicted vs actual survival for 2,518 test set patients at landmark time t0 (first visit after diagnosis of metastatic cancer)

Predicted median survival in monthsActual median survival in months (95% CI)
0-3 (n = 106)1.3 (0.9-2.0)
3.1-6 (n = 172)3.7 (2.5-5.2)
6.1-12 (n = 382)6.7 (5.6-7.9)
>12 (n = 1858)35.7 (31.8-39.1)

Conclusions

The model showed high predictive performance, which was significantly better than that of an existing model. Because it is fully automated, the model can be used to examine providers’ practice patterns and could deployed in a decision support tool to help improve quality of care.

Legal entity responsible for the study

Michael Gensheimer.

Funding

National Institutes of Health.

Disclosure

M.F. Gensheimer: Research funding: Varian Medical Systems, Philips Healthcare. E. Cho: Employee of Genentech. D. Rubin: Research funding: Philips Healthcare. D.T. Chang: Research funding, honoraria: Varian Medical Systems; Stock ownership: ViewRay. All other authors have declared no conflicts of interest.

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Proffered paper session - Supportive and palliative care Proffered Paper session

1539O - Posttraumatic Growth and Death anxiety in Caregivers of Cancer Patients: PHOENIX Study

Presentation Number
1539O
Lecture Time
15:48 - 16:00
Speakers
  • Ali Alkan (Osmaniye, TR)
Location
Hall B3 - Room 20, ICM München, Munich, Germany
Date
21.10.2018
Time
14:45 - 16:15

Abstract

Background

Post traumatic growth (PTG) is defined as a positive psychological change that occurs following a meaningfully challenging or traumatic life event. The purpose of the study is to define the predictors of PTG and death anxiety (DAN) in care givers of cancer patients and evaluate the impact of DAN on PTG.

Methods

The study is designed as a multicenter survey study. Caregivers of cancer patients were evaluated with structured questionnaires to assess the DAN and PTG and clinical parameters associated with them. The validated PTG scale and Templer death anxiety scale were used.

Results

Between August 2017 and April 2018, 426 participants were evaluated in 3 different cancer centers. 361 (84.7%) participants declared that they had high level of impact on their daily life after the diagnosis. Being spouse of the patient, age more than 40, female sex, being married, presence of sibling and high DAN scores were associated with high PTG scores. In multivariate analysis, high DAN scores were the only parameter associated with high PTG scores. (OR: 1.6, CI (95%) 1.02-2.5, p = 0.03). Caring elderly patients, female sex, presence of siblings, low income, not working, presence of chronic disease and history of psychiatry admission were associated with high DAN scores. In multivariate analysis, female sex was the only risk factor for high DAN scores. (OR: 1.6, CI(95%) 1.1-2.8). There was a positive correlation between PTG and DAN scores (r = 0.15, p = 0.001). Higher DAN scores were associated with positive impacts on self perception (37 vs 35, p = 0.02), philosophy of life (16.0 vs 13.0, p = 0.035) and changes in relationship (16.0 vs 14.0, p = 0.01).

High PTG score
High DAN score
ORCI (95%)pORCI (95%)p
Being spouse1.10.6-1.90.57
>40 years of age1.10.7-1.70.60
Married1.60.8-3.20.11
Being female1.40.9-2.20.0551.61.1-2.80.049
Having sibling1.30.6-2.70.431.50.91-2.520.10
High TDA score1.61.02-2.50.031.50.9-2.30.07
Low income1.310.8-2.00.24
Not working1.580.9-2.70.10
Chronic disease present1.00.5-1.60.99
Psychiatry admission1.20.6-2.30.52
High PTG score1.50.9-2.30.07

Conclusions

It’s the first data about the association between DAN and PTG. We found a positive impact of death anxiety on positive psychological changes in caregivers of cancer patients. This association should be further studied including spiritual experiences, religious perspective and family relations.

Legal entity responsible for the study

Ali Alkan.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.

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Proffered paper session - Supportive and palliative care Proffered Paper session

Invited Discussant 1512O and 1539O

Lecture Time
16:00 - 16:15
Speakers
  • Luzia Travado (Lisbon, PT)
Location
Hall B3 - Room 20, ICM München, Munich, Germany
Date
21.10.2018
Time
14:45 - 16:15