Abstract 1755
Background
PAN26 was developed as a supplement to the EORTC QLQ-C30 to assess pancreatic cancer–specific health-related quality of life (HRQoL) issues. Despite its use in clinical trials, PAN26 MID has not been established. In undertaking the most comprehensive evaluation to date of PAN26’s measurement properties in patients with surgically resected pancreatic cancer receiving adjuvant therapy, we used distribution-based minimum detectable change (MDC) and anchor-based methods to determine PAN26 scale MIDs using the data collected during the Adjuvant Pancreatic Adenocarcinoma Clinical Trial (APACT).
Methods
PAN26 and QLQ-C30 scores were assessed in 12-week intervals at screening (BL), middle and end of treatment, and up to 2.5 years of follow-up. MDC values were calculated via BL standard deviation (SD) and reliability-biased standard error of measurement approaches. Anchor-based values were determined via a linear mixed model in which QLQ-C30 overall health (OH; Item 29) served as a serial patient global impression of severity anchor for predicting PAN26 scores. Pattern-mixture models (PMM) were fit to assess the impact of attrition on estimates.
Results
MDC values were in the 12 to 15 range (Table). These findings were consistent with SD-based values inferred from earlier studies, although our results extended to standalone items. Anchor-based MIDs were almost twice as sensitive as MDC, with values in the 5 to 9 range (PMM values almost identical). Anchor values could not be inferred for the PAN26 bowel, hepatic, and healthcare scales and gas item due to their low (r < 0.30) correlation with OH.Table:
687P PAN26 anchor (QLQ-C30 overall health) and distribution-derived MID
Scale/Item | Anchor | Distribution | ||
---|---|---|---|---|
Estimate | SE | 1/2 BLSD | SEM | |
Altered bowel habit | –a | 12.5 | 11.8 | |
Body image | 6.4 | 0.3 | 13.1 | 13.5 |
Digestive symptoms | 6.0 | 0.3 | 13.4 | 16.2 |
Hepatic | – a | 7.6 | 11.4 | |
Pancreatic pain | 5.6 | 0.2 | 9.7 | 9.7 |
Satisfaction with health care | – a | 12.1 | 15.3 | |
Sexual dysfunction | 5.4 | 0.4 | 17.3 | 19.7 |
Bloated | 4.9 | 0.3 | 12.8 | 15.9 |
Dry mouth | 5.1 | 0.3 | 13.4 | 15.6 |
Gas | – a | 14.5 | 16.2 | |
Indigestion | 4.8 | 0.3 | 12.8 | 15.7 |
Limited activities | 8.0 | 0.3 | 15.4 | 21.7 |
Low weight | 5.3 | 0.3 | 14.8 | 20.5 |
Taste different | 7.5 | 0.3 | 13.6 | 19.7 |
Troubled by tx adverse events | 8.8 | 0.3 | 12.6 | 15.8 |
Weak arms/legs | 9.1 | 0.3 | 13.1 | 15.7 |
Worried about future health | 6.3 | 0.3 | 15.5 | 16.3 |
BLSD, baseline standard deviation; SE, standard error; SEM, standard error of measurement (based on intraclass correlation).
aLow r (< 0.3) with overall health.
Conclusions
The MID estimates for PAN26 subscales can help clinicians and researchers interpret the changes in HRQoL and determine sample sizes in the design of future clinical trials.
Clinical trial identification
Editorial acknowledgement
Pharmerit International.
Legal entity responsible for the study
The authors.
Funding
Celgene Corporation.
Disclosure
M. Reni: Non-remunerated activity/ies, Personal Fees: Celgene, Baxalta, Shire, Eli Lilly, Pfizer, Novocure, Novartis, AstraZeneca. J. Braverman: Full / Part-time employment: Celgene Corporation. T. Macarulla Mercade: Honoraria (self): Roche, Sanofi, Tesaro, Shire, Genzyme; Advisory / Consultancy: Baxalta, Celgene, H3B, QED, Shire; Speaker Bureau / Expert testimony: Celgene, Sanofi/Aventis, Shire; Research grant / Funding (self): Agios, Aslan, AstraZeneca, Bayer, Celgene, Genetech, Hallozyme, Immunomedics, Lilly, Merimarck, Millennium, Novartis, Novocure, Pfizer, Pharmacyclics, Roche; Travel / Accommodation / Expenses: Bayer, H3B, Merck, Sanofi. D. Oh: Advisory / Consultancy: Genentech/Roche, AstraZeneca, Novartis, Merck Serono, Bayer, Taiho, ASLAN, Halozyme, Zymeworks; Research grant / Funding (institution): AstraZeneca, Novartis, Array, Eli Lilly. H. Riess: Non-remunerated activity/ies, Personal Fees: Celgene, Roche, Shire. M.A. Tempero: Advisory / Consultancy: AbbVie, Advance Medical, BioPharm Communications, BMS, Celgene, Eisai, Ignyta, Pharmacyslics, Pharmcyte Biotech, Tocagen; Advisory / Consultancy: AstraZeneca, CPRIT, Immunovia; Research grant / Funding (institution): Halozyme. B. Lu: Shareholder / Stockholder / Stock options, Full / Part-time employment: Celgene Corporation. J. Marcus: Full / Part-time employment: Pharmerit international; Advisory / Consultancy, Research grant / Funding (self): Celgene Corporation. N. Joshi: Full / Part-time employment: Pharmerit International; Advisory / Consultancy: Celgene Corporation. M. Botterman: Honoraria (institution): Celgene, Bayer, Daiichi, BMS. All other authors have declared no conflicts of interest.
Resources from the same session
5063 - Does Nutritional Status Affect Treatment Tolarability, Response and Survival in Metastatic Gastric Cancer Patients? Results of Prospective Multicenter Study
Presenter: Senem Karabulut
Session: Poster Display session 2
Resources:
Abstract
2717 - Ramucirumab use in patients with Advanced Gastric Cancer (AGC) or gastro-oesophageal junction (GEJ) adenocarcinoma in Spain: RAMIS observational study
Presenter: Federico Longo Munoz
Session: Poster Display session 2
Resources:
Abstract
3187 - Gastrectomy plus chemotherapy versus chemotherapy alone for advanced gastric cancer with a single non-curable factor: Exploratory analysis in the patients who were enrolled in JCOG0705/KGCA01 phase III trial (REGATTA) and could continue chemotherapy
Presenter: Takaki Yoshikawa
Session: Poster Display session 2
Resources:
Abstract
4765 - A prospective observational study on the optimal maintenance strategy in HER2-positive advanced gastric cancer treated with trastuzumab based therapy
Presenter: Qian Li
Session: Poster Display session 2
Resources:
Abstract
3500 - Randomised phase 2 trial of first-line docetaxel, carboplatin, capecitabine (CTX) and epirubicin, oxaliplatin, capecitabine (EOX) in advanced esophagogastric adenocarcinoma (SEED)
Presenter: Peter Petersen
Session: Poster Display session 2
Resources:
Abstract
5197 - Ramucirumab in the treatment of refractory metastatic gastric cancer: results from the RamSelGa trial.
Presenter: Alexey Tryakin
Session: Poster Display session 2
Resources:
Abstract
2011 - Regorafenib in combination with Paclitaxel for beyond first-line treatment of advanced esophagogastric cancer (REPEAT): a phase Ib trial with expansion cohort
Presenter: Mohammed Khurshed
Session: Poster Display session 2
Resources:
Abstract
2117 - The relationship between the survival and fixed dosing of S-1 in advanced gastric cancer patients by pooled analysis using individual data from four Japanese randomized phase III trials
Presenter: Wataru Ichikawa
Session: Poster Display session 2
Resources:
Abstract
2669 - A Phase 1b Study of Oraxol in Combination with Ramucirumab in Patients with Gastric or Esophageal Cancers who failed previous chemotherapy
Presenter: Ming Huang Chen
Session: Poster Display session 2
Resources:
Abstract
3240 - Efficacy and safety of trifluridine/tipiracil (FTD/TPI) in European patients with heavily pretreated metastatic gastric cancer (mGC): an analysis of the TAGS study
Presenter: Maria Alsina
Session: Poster Display session 2
Resources:
Abstract