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
3034 - Efficacy and safety of neoadjuvant chemotherapy plus trastuzumab and pertuzumab in non-metastatic HER2-positive breast cancer in real life: NEOPEARL STUDY
Presenter: Maria Agnese Fabbri
Session: Poster Display session 2
Resources:
Abstract
4772 - Real world comparison of the impact of adjuvant capecitabine in women with high-risk triple-negative breast cancer after neoadjuvant chemotherapy
Presenter: Maysa Vilbert
Session: Poster Display session 2
Resources:
Abstract
5627 - Influence of age on the indication of adjuvant chemotherapy in early breast cancer using Oncotype DX. An analysis of 240 patients treated in the Institut Catala d’Oncologia (ICO) hospitals
Presenter: Sabela Recalde
Session: Poster Display session 2
Resources:
Abstract
3917 - Impact of delayed neoadjuvant systemic chemotherapy on survival among breast cancer patients
Presenter: Mariana Chavez Mac Gregor
Session: Poster Display session 2
Resources:
Abstract
2246 - Clinical Confirmation of Higher Exposure to Niraparib in Tumor vs Plasma in Patients With Breast Cancer
Presenter: Laura Spring
Session: Poster Display session 2
Resources:
Abstract
581 - The rationale for the effectiveness of systemic treatment of breast cancer depending on the body weight index
Presenter: Mohammad Hojouj
Session: Poster Display session 2
Resources:
Abstract
5327 - Response to neoadjuvant chemotherapy in HER2 non-overexpressing breast cancer subtypes
Presenter: Silvia Mihaela Ilie
Session: Poster Display session 2
Resources:
Abstract
3613 - Pre-specified interim analysis of the SAFE trial (NCT2236806): a 4-arm randomized, double-blind, controlled study evaluating the efficacy and safety of cardiotoxicity prevention in non-metastatic breast cancer patients treated with anthracyclines with or without trastuzumab.
Presenter: Lorenzo Livi
Session: Poster Display session 2
Resources:
Abstract
3736 - Safety of hypofractionated whole breast irradiation after conservative surgery for patients aged less than 60 years: a multi-center comparative study.
Presenter: Icro Meattini
Session: Poster Display session 2
Resources:
Abstract
5085 - Usefulness of NT-ProBNP as a biomarker of cardiotoxicity in breast cancer patients treated with trastuzumab
Presenter: Isabel Blancas López-Barajas
Session: Poster Display session 2
Resources:
Abstract