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
5295 - Predictive factors and survival outcomes with stereotactic body radiation therapy in treatment of oligometastases in colorectal cancer
Presenter: Vibhay Pareek
Session: Poster Display session 2
Resources:
Abstract
5887 - Factors of importance in procuring tumoroids from colorectal liver metastasis biopsies for precision medicine.
Presenter: Lars Henrik Jensen
Session: Poster Display session 2
Resources:
Abstract
2196 - FUSAFE individual patient data meta-analysis (MA) to assess the performance of dihydropyrimidine dehydrogenase (DPD) gene polymorphisms for predicting grade 4-5 fluoropyrimidine (FP) toxicity
Presenter: Marie-Christine Etienne-Grimaldi
Session: Poster Display session 2
Resources:
Abstract
2859 - Treatments (tx) after progression to first-line FOLFOXIRI + bevacizumab (bev) in metastatic colorectal cancer (mCRC) patients (pts): A pooled analysis of TRIBE and TRIBE-2 studies by GONO.
Presenter: Daniele Rossini
Session: Poster Display session 2
Resources:
Abstract
3888 - Randomized phase III study of sequential treatment with capecitabine or 5-fluorouracil (FP) plus bevacizumab (BEV) followed by the addition with oxaliplatin (OX) versus initial combination with OX+FP+ BEV in the first-line chemotherapy for metastatic colorectal cancer: The C-cubed study
Presenter: Takeshi Nagasaka
Session: Poster Display session 2
Resources:
Abstract
1065 - Early tumour shrinkage (ETS), depth of response (DpR) and associated survival outcomes in patients (pts) with RAS wild type (WT) metastatic colorectal cancer (mCRC) classified according to Köhne prognostic category: retrospective analysis of the panitumumab (Pmab) PRIME study
Presenter: Andrea Sartore-Bianchi
Session: Poster Display session 2
Resources:
Abstract
1702 - Randomized phase II trial of CAPOX with planned oxaliplatin stop-and-go strategy as adjuvant chemotherapy after curative resection of colon cancer (CCOG-1302 study)
Presenter: Hiroyuki Yokoyama
Session: Poster Display session 2
Resources:
Abstract
5104 - A metabolomic recurrence score for risk-stratification of elderly patients (pts) with early colorectal cancer (eCRC)
Presenter: Samantha Di Donato
Session: Poster Display session 2
Resources:
Abstract
5285 - RAS mutant allele fraction in plasma predicts benefit to anti-angiogenic based first line treatment in metastatic colorectal cancer
Presenter: Giulia Martini
Session: Poster Display session 2
Resources:
Abstract
1790 - Impact of prophylactic systemic antibiotics (SA) on outcome of patients (pts) with RAS-wildtype (RAS-wt) metastatic colorectal carcinoma (mCRC) treated with cetuximab-based first-line therapy. Subgroup analysis of the german non-interventional study ERBITAG
Presenter: Stephan Sahm
Session: Poster Display session 2
Resources:
Abstract