Abstract 1025
Background
The AJCC classifies LM of iCCA as early stage: T2b [stage II/IVa (AJCCv.7) and stage II/III (AJCCv.8) if N0/N1, respectively]; in contrast, LM are perceived by clinicians to be of poorer prognosis than other early stages.
Methods
Eligible patients (pts): iCCA from the ENS-CCA registry with survival / staging (AJCCv.7) data. Patients were classified: Group (g) A: stages I-III (excluding T2bN0); gB: stage IVa (excluding T2bN1M0); gC: LM (T2bN0/1); gD: stage IVb (M1 extra-hepatic disease). Primary end-point: overall survival (OS) (time from first diagnosis to death/last visit). Survival analysis was performed in a training set (TS) and findings validated in a validation set (VS); Kaplan Meier and Cox Regression. Sensitivity analysis (SA) was performed limiting gC to N0.
Results
Of 1,820 pts (810 iCCA), 574 were eligible (141 TS; 433 VS). Following the new classification, 114 stage I-IVa pts (28.9%) were re-classified into the gC (75 N0; 39 N1): gA (192 pts; 33.5%), gB (89; 15.5), gC (114;19.8), gD (179; 31.2). In the TS, multivariate Cox Regression was adjusted for obesity (p 0.026) and performance status (p < 0.001); pts in gA (HR 0.39 (95%CI 0.18-0.85); p 0.017) had a lower risk of death (vs gC); gB and gD showed a trend towards better and shorter survival (vs gC), respectively, but differences did not reach statistical significance (p 0.109 and 0.737, respectively). Findings were validated in the VS: gA (vs gC) HR 0.34 (95%CI 0.24-0.49); p < 0.001. SA (whole series) confirmed independence from N1 status [gA (vs gC) HR 0.39 (95%CI 0.28-0.57); p < 0.001)]. Table shows outcome data for all stages (whole series).Table:
731P
Whole series (n = 574) | Freq (%) | OS (months) median (95%CI) | Multivariate Cox Regression HR (95% CI); p |
---|---|---|---|
Group A (AJCC v.7 stage I) | 19.7 | 41.8 (32.5-52.2) | 0.28 (0.19-0.40); < 0.001 |
Group A (AJCC v.7 stage II; excluding T2bN0) | 5.6 | 31.3 (18.5-41.4) | 0.48 (0.28-0.82); 0.007 |
Group A (AJCC v.7 stage III) | 8.2 | 23.5 (14.1-27.3) | 0.45 (0.29-0.69); < 0.001 |
Group B (AJCC v.7 stage IVa; excluding T2bN1) | 15.5 | 14.9 (11.6-21.7) | 0.77 (0.55-1.07); 0.118 |
Group C (LM; AJCC v.7 T2bN0/N1) | 19.9 | 10.9 (7.5-15.9) | 1 (Ref); n/a |
Group D (AJCC v.7 stage IVb) | 31.1 | 8.4 (5.9-10.3) | 1.17 (0.89-1.54); 0.247 |
Conclusions
LM from iCCA have a worse outcome than other early stages (I-III). Unfortunately, the latest version of AJCC (AJCC v.8) does not take this into consideration; further changes in the AJCC classification are warranted.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
European Network for the Study of Cholangiocarcinoma (ENS-CCA).
Funding
ENS-CCA received funding from EASL Registry Award 2016 and Support from the Spanish Association of Gastroenterology (AEG), for the development of this registry; Dr Angela Lamarca received funding from Conquer Cancer Foundation of the American Society of Clinical Oncology (YIA 2017) and The Christie Charity.
Disclosure
A. Lamarca: Speaker Bureau / Expert testimony: Merck; Speaker Bureau / Expert testimony, Research grant / Funding (self), Travel / Accommodation / Expenses: Ipsen; Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Pfizer; Travel / Accommodation / Expenses: Novartis; Travel / Accommodation / Expenses: Abott Nutrition; Travel / Accommodation / Expenses: Celgene; Travel / Accommodation / Expenses: AAA; Travel / Accommodation / Expenses: Sirtex Medical; Travel / Accommodation / Expenses: Bayer; Travel / Accommodation / Expenses: Delcath; Travel / Accommodation / Expenses: Mylan; Advisory / Consultancy: Eisai; Advisory / Consultancy: Nutricia. A. La Casta: Travel / Accommodation / Expenses: Celgene; Travel / Accommodation / Expenses: Ipsen; Travel / Accommodation / Expenses: Roche. A. Forner: Advisory / Consultancy: Guerbet; Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Bayer; Speaker Bureau / Expert testimony: BTG. V. Cardinale: Licensing / Royalties: VESTA Therapeutics. D. Alvaro: Research grant / Funding (self), Licensing / Royalties: VESTA Therapeutics; Research grant / Funding (self): Intercept Pharmaceuticals. J.W. Valle: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Ipsen; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Novartis; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Merck; Advisory / Consultancy: Delcath Systems; Advisory / Consultancy: Agios; Advisory / Consultancy: Pfizer; Advisory / Consultancy: PCI Biotech; Advisory / Consultancy: Incyte; Advisory / Consultancy: Keocyt; Advisory / Consultancy: QED Therapeutics; Advisory / Consultancy: Pieris Pharmaceuticals; Advisory / Consultancy: Genoscience Pharma; Advisory / Consultancy: Mundipharma EDO GmbH; Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Nucana; Speaker Bureau / Expert testimony: Imaging Equipment Limited; Travel / Accommodation / Expenses: Celgene. All other authors have declared no conflicts of interest.
Resources from the same session
3516 - Palbociclib Rechallenge in Hormone Receptor (HR)[+]/HER2[-] Advanced Breast Cancer (ABC). PALMIRA Trial
Presenter: Antonio Llombart Cussac
Session: Poster Display session 2
Resources:
Abstract
4616 - Alpelisib (ALP) + Endocrine Therapy (ET) by Last Prior Therapy in Patients (pts) With PIK3CA-Mutated Hormone-Receptor Positive (HR+) Human Epidermal Growth Factor Receptor-2-Negative (HER2–) Advanced Breast Cancer (ABC): Additional Study Cohort in BYLieve
Presenter: Eva Ciruelos
Session: Poster Display session 2
Resources:
Abstract
3592 - PRECYCLE: Impact of CANKADO-based eHealth-support on quality of life in metastatic breast cancer patients treated with palbociclib and endocrine therapy.
Presenter: Tom Degenhardt
Session: Poster Display session 2
Resources:
Abstract
4168 - Efficacy and safety of oral poly (ADP-ribose) polymerase inhibitor fluzoparib in patients with BRCA1/2 mutations and platinum sensitive recurrent ovarian cancer
Presenter: Ning Li
Session: Poster Display session 2
Resources:
Abstract
2785 - Effect of response to last platinum-based chemotherapy in patients (pts) with platinum-sensitive, recurrent ovarian carcinoma in the phase 3 study ARIEL3 of rucaparib maintenance treatment
Presenter: Jonathan Ledermann
Session: Poster Display session 2
Resources:
Abstract
3496 - Integrated safety analysis of the poly(ADP-ribose) polymerase (PARP) inhibitor rucaparib in patients (pts) with ovarian cancer in the treatment and maintenance settings
Presenter: Rebecca Kristeleit
Session: Poster Display session 2
Resources:
Abstract
2844 - Clinical factors associated with prolonged response and survival under olaparib as maintenance therapy in BRCA mutated ovarian cancers
Presenter: S.Intidhar Labidi-Galy
Session: Poster Display session 2
Resources:
Abstract
1955 - A Prospective Evaluation of Tolerability of Niraparib Dosing Based on Baseline Body Weight (BW) and Platelet (plt) Count: Blinded Pooled Interim Safety Data from the NORA Study
Presenter: Xiaohua Wu
Session: Poster Display session 2
Resources:
Abstract
2539 - Evaluation of Niraparib 200 mg/d as Maintenance Therapy in Recurrent Ovarian Cancer and Associated Thrombocytopenia in a Real-World US Setting
Presenter: Premal Thaker
Session: Poster Display session 2
Resources:
Abstract
1290 - Niraparib initial dose and its’ management in patients with recurrent high-grade serous ovarian cancer.
Presenter: Jacek Grabowski
Session: Poster Display session 2
Resources:
Abstract