scholarly journals The role of opioids in cancer response to immunotherapy

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Andrea Botticelli ◽  
Alessio Cirillo ◽  
Giulia Pomati ◽  
Bruna Cerbelli ◽  
Simone Scagnoli ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
Immune System ◽  
Progression Free Survival ◽  
Concomitant Administration ◽  
Tumor Burden ◽  
Cox Proportional Hazard ◽  
Immunomodulatory Action ◽  
Immune System Modulation ◽  
Ecog Ps ◽  
The Impact

Abstract Background The response to immunotherapy can be impaired by several factors including external intervention such as drug interactions with immune system. We aimed to examine the immunomodulatory action of opioids, since immune cells express opioid receptors able to negatively influence their activities. Methods This observational, multicenter, retrospective study, recruited patients with different metastatic solid tumors, who have received immunotherapy between September 2014 and September 2019. Immunotherapy was administered according to the standard schedule approved for each primary tumor and line of treatment. The concomitant intake of antibiotics, antifungals, corticosteroids and opioids were evaluated in all included patients. The relationship between tumor response to immunotherapy and the oncological outcomes were evaluated. A multivariate Cox-proportional hazard model was used to identify independent prognostic factors for survival. Results One hundred ninety-three patients were recruited. Overall, progression-free survival (PFS) and overall survival (OS) were significantly shorter in those patients taking opioids than in those who didn’t (median PFS, 3 months vs. 19 months, HR 1.70, 95% CI 1.37–2.09, p < 0.0001; median OS, 4 months vs. 35 months, HR 1.60, 95% CI 1.26–2.02, p < 0.0001). In addition, PFS and OS were significantly impaired in those patients taking corticosteroids, antibiotics or antifungals, in those patients with an ECOG PS ≥ 1 and in patients with a high tumor burden. Using the multivariate analyses, opioids and ECOG PS were independent prognostic factors for PFS, whereas only ECOG PS resulted to be an independent prognostic factor for OS, with trend toward significance for opioids as well as tumor burden. Discussion Our study suggests that the concomitant administration of drugs as well as some clinical features could negatively predict the outcomes of cancer patients receiving immunotherapy. In particular, opioids use during immunotherapy is associated with early progression, potentially representing a predictive factor for PFS and negatively influencing OS as well. Conclusions A possible negative drug interaction able to impair the immune response to anti-PD-1/PD-L1 agents has been highlighted. Our findings suggest the need to further explore the impact of opioids on immune system modulation and their role in restoring the response to immunotherapy treatment, thereby improving patients' outcomes.

scholarly journals The Role of Opioids in Cancer Response to Immunotherapy

2021 ◽  
Author(s):  
Andrea Botticelli ◽  
Alessio Cirillo ◽  
Giulia Pomati ◽  
Bruna Cerbelli ◽  
Simone Scagnoli ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
Immune System ◽  
Progression Free Survival ◽  
Concomitant Administration ◽  
Tumor Burden ◽  
Cox Proportional Hazard ◽  
Immunomodulatory Action ◽  
Immune System Modulation ◽  
Ecog Ps ◽  
The Impact

Abstract Background: The response to immunotherapy can be impaired by several factors including external intervention such as drug interactions with immune system. We aimed to examine the immunomodulatory action of opioids, since immune cells express opioid receptors able to negatively influence their activities.Methods: This observational, multicenter, retrospective study, recruited patients with different metastatic solid tumors, who have received immunotherapy between September 2014 and September 2019. Immunotherapy was administered according to the standard schedule approved for each primary tumor and line of treatment. The concomitant intake of antibiotics, antifungals, corticosteroids and opioids were evaluated in all included patients. The relationship between tumor response to immunotherapy and the oncological outcomes were evaluated. A multivariate Cox-proportional hazard model was used to identify independent prognostic factors for survival. Results: One hundred ninety-three patients were recruited. Overall, progression-free survival (PFS) and overall survival (OS) were significantly shorter in those patients taking opioids than in those who didn’t (median PFS, 3 months vs. 19 months, HR 1.70, 95% CI 1.37-2.09, p<0.0001; median OS, 4 months vs. 35months, HR 1.60, 95 % CI 1.26-2.02, p <0.0001). In addition, PFS and OS were significantly impaired in those patients taking corticosteroids, antibiotics or antifungals, in those patients with an ECOG PS ≥1 and in patients with a high tumor burden. Using the multivariate analyses, opioids and ECOG PS were independent prognostic factors for PFS, whereas only ECOG PS resulted to be an independent prognostic factor for OS, with trend toward significance for opioids as well as tumor burden.Discussion: Our study suggests that the concomitant administration of drugs as well as some clinical features could negatively predict the outcomes of cancer patients receiving immunotherapy. In particular, opioids use during immunotherapy is associated with early progression, potentially representing a predictive factor for PFS and negatively influencing OS as well. Conclusions: A possible negative drug interaction able to impair the immune response to anti-PD-1/PD-L1 agents has been highlighted. Our findings suggest the need to further explore the impact of opioids on immune system modulation and their role in restoring the response to immunotherapy treatment, thereby improving patients' outcomes.

The impact of prior chemotherapy (PrC) on immunotherapy outcomes in non-small cell lung cancer (NSCLC) patients: Real data from a mono-institutional study.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e21639-e21639
Author(s):  
Marianna Macerelli ◽  
Simona Rizzato ◽  
Marco Giavarra ◽  
Francesca Valent ◽  
Monica Cattaneo ◽  
...  
Keyword(s):  
Predictive Biomarkers ◽  
Progression Free Survival ◽  
Real Data ◽  
Tumor Burden ◽  
Interquartile Range ◽  
Best Response ◽  
Before And After ◽  
Ecog Ps ◽  
Nsclc Patients ◽  
The Impact

e21639 Background: Immunotherapy has changed the paradigm on NSCLC treatment. No widespread and reproducible predictive biomarkers have been established. We analyzed how PrC could affect ICI outcomes. Methods: We conducted a retrospective observational study and analyzed all NSCLC patients (pts) treated with ICI (nivolumab or atezolizumab or pembrolizumab) in our institution from 2015 to 2018 and followed until January 2020. All pts had received at least one PrC. We recorded clinical features of pts both before and after ICI treatment. Results: A total of 83 pts were included, with a median age of 69 (range, 47-82). Sixty pts (73%) were male, 74 (89%) were smokers and 81 (97%) had ECOG PS 0-1. Thirteen (15.7%) pts had a immune-related toxicity (iRT, G1-G2 76.9% and G3-G4 23.1%) and 21 (25.3%) continued ICI therapy beyond progression disease (PD). Patients with a PD as best response to PrC had more probability to reach a PD with ICI (p = 0.06). Median Progression-Free Survival (PFS) on ICI was 2.9 months (interquartile range, 1.9-9.4) with no statistical difference between pts with oligo- or diffuse progression (≤ or > 5 metastasis) during PrC (p = 0.42). Corticosteroids use was associated with worse PFS (p < 0.01). Median Overall Survival (OS) was 9.1 months (interquartile range, 3.3-26.5), with a benefit for pts with a stable disease (SD) or partial response (PR) to PrC (p = 0.02), for pts who experimented iRT (p = 0.04) and who didn’t receive corticosteroids (p < 0.01). In multivariate analysis liver or brain metastases (HR 8.8, 95% CI 2.9-26.8 and HR 2.2, 95% CI 0.6-8.1), coticosteroids use (HR 3.7, 95% CI 1.3-10.5) or previous cisplatin-based chemotherapy (HR 8.4, 95% CI 2.3-30.1) were associated with worse OS. Instead, pts whit iRT (HR 0.4, 95% CI 0.1-1.3) and PR as best response to PrC (HR 0.8, 95% CI 0.3-2.0) had a better OS. Conclusions: Our study confirms literature data and suggests that PrC could affect ICI outcomes. Tumor burden seems not to influence ICI outcomes, unlike response rate to PrC. Systemic corticosteroids use and iRT predicts ICI outcomes.

Final results of phase II study of S-1, oral leucovorin, oxaliplatin, and bevacizumab combination therapy (SOL+BV; SOLA) in metastatic colorectal cancer (mCRC).

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 574-574 ◽  
Author(s):  
Kentaro Yamazaki ◽  
Tomohiro Nishina ◽  
Takeshi Kato ◽  
Takayuki Yoshino ◽  
Yoshinori Miyata ◽  
...  
Keyword(s):  
Survival Rate ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Present Report ◽  
Sensory Neuropathy ◽  
Progression Free Survival ◽  
Target Lesion ◽  
Ecog Ps ◽  
The Impact

574 Background: The SOL regimen (S-1, Oral Leucovorin; LV, and Oxaliplatin) demonstrated a promising activity with tolerated toxicities compared to mFOLFOX6 in a randomized phase II study for mCRC. We previously reported the promising results of a phase II study of SOL+BV in Gastrointestinal Cancers Symposium 2012 (Kato T, et al.) focusing on early clinical outcomes, overall response rate (ORR), progression free survival (PFS) and safety. The final follow-up (cut-off date Dec 2012) has been completed, and we report up-dated overall survival (OS) and the impact of early objective tumor response (EOTR) on OS in the present report. Methods: The main inclusion criteria were; (1) metastatic colorectal adenocarcinoma, (2) age ≥20 years, (3) no prior chemotherapy, (4) target lesion (RECIST v1.0), (5) ECOG PS 0-1, 6) written informed consent. Patients (pts) received S-1 (40-60 mg bid) and LV (25 mg bid) orally for one week. Oxaliplatin (85 mg/m2) and BV (5 mg/kg) were administered on day 1. This treatment was repeated every 2 weeks. The primary endpoint was ORR confirmed by the independent review committee according to RECIST v1.0. This trial was supported by Taiho Pharmaceutical CO, LTD. (JAPIC Clinical Trials information Identifier: JapicCTI-090881). Results: From Oct 2009 to Apr 2010, 31 pts were enrolled. Of the eligible 29 pts, median age was 62; PS 0/1 was 24/5; number of metastatic organs 1/≥2 was 15/14. ORR was 86% (95%CI, 68-96), and the median PFS was 15 months (95%CI, 10-26). OS has not reached median with a median follow-up time of 34 months. Two-year survival rate was 72%. EOTR (RECIST sum ≥30% shrinkage) at 6-weeks was observed in 35% of pts. Two-year survival rate in these pts with an EOTR at 6-weeks was 80%, while in other pts without an EOTR at 6-weeks was 68%. The curative resection rate of metastatic lesions was 28%. The incidence (≥10%) of grade 3/4 adverse drug reactions were; neutropenia 20%, hypertension 23%, anorexia 20%, fatigue 17%, diarrhea 10%, and sensory neuropathy 53%. Conclusions: The SOL+BV regimen showed the promising activity for mCRC. The high proportion of EOTR might lead to long survival. Further evaluation of this regimen would be warranted. Clinical trial information: 090881.

Prognostic factors for PFS in patients with advanced gastric cancer: Using the data from JCOG9912 study.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 180-180
Author(s):  
Daisuke Takahari ◽  
Narikazu Boku ◽  
Junki Mizusawa ◽  
Kenichi Nakamura ◽  
Yasuhide Yamada ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Multivariate Analysis ◽  
Prognostic Factors ◽  
Advanced Gastric Cancer ◽  
Prognostic Index ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Treatment Regimens ◽  
Cox Proportional Hazard ◽  
Metastatic Sites

180 Background: In advanced gastric cancer (AGC), there are many reports about prognostic factors for overall survival (OS), and we have proposed a prognostic index using four prognostic factors (PS, number of metastatic sites, prior gastrectomy and ALP; Oncologist 2014) based on a phase III trial JCOG 9912 for the first-line treatment (Lancet Oncol. 2009). However, there is no report about prognostic factors for progression free survival (PFS). In this ancillary study, we explored whether prognostic factors are similar or not between OS and PFS. Methods: The subjects of this study were selected from the JCOG9912 which intended to confirm the superiority of irinotecan plus cisplatin (IP) and the non-inferiority of S-1 to5-FU for patients with AGC. Of all enrolled patients in JCOG9912, those who had target lesions and whose complete data were available were analyzed with multivariate analysis using Cox proportional hazard model. Results: 492 out of the 703 pts of JCOG9912 were analyzed, who received either 5-FU (n=163), IP (n=164) or S-1(n=165). The median PFS was 3.7 months for all the subjects, and 2.2 months for 5-FU, 4.9 months for IP and 3.8 months for S-1. Multivariate analysis in all 492 analyzed patients demonstrated seven independent prognostic factors for PFS (Table). Prognostic factors in each treatment were; sex (HR 1.66, 95%CI 1.11-2.49), PS (1.51, 1.04-2.18), Ca (0.39, 0.17-0.86), GPT (2.46, 1.30-4.66) and LDH (1.67, 1.16-2.48) in 5-FU, sex (1.77, 1.10-2.86) in IP, and Na (2.00, 1.01-3.99) and creatinine clearance (0.37, 0.15-0.93) in S-1. Conclusions: There were no common prognostic factors among the three treatment regimens. Prognostic factors for PFS may be different by treatment regimen, although further investigations with larger sample size are needed. [Table: see text]

Primary (1°) tumor location as an independent prognostic marker from molecular features for overall survival (OS) in patients (pts) with metastatic colorectal cancer (mCRC): Analysis of CALGB / SWOG 80405 (Alliance).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 3503-3503 ◽  
Author(s):  
Alan P. Venook ◽  
Fang-Shu Ou ◽  
Heinz-Josef Lenz ◽  
Omar Kabbarah ◽  
Xueping Qu ◽  
...  
Keyword(s):  
Prognostic Marker ◽  
Molecular Subtype ◽  
Progression Free Survival ◽  
Molecular Data ◽  
Tumor Location ◽  
Tumor Burden ◽  
Independent Prognostic Marker ◽  
Molecular Features ◽  
Metastatic Sites ◽  
The Impact

3503 Background: 80405 found no OS or Progression Free Survival (PFS) difference when bevacizumab (BV) or cetuximab (Cet) was added to 1st-line FOLFOX or FOLFIRI in All RAS wild type (wt) mCRC pts. There was a significant 1° side by biologic interaction (P int: OS = 0.008, PFS = 0.001) favoring pts with left-sided (L) 1°. Analyses of 1° tumors beyond All RAS includes Consensus Molecular Subtype (CMS), BRAF and MSI. (CMS results - see Lenz et al; BRAF -see Innocenti et al) We asked whether 1° tumor location - L vs right (R) - is an independent prognostic marker when these other molecular features are considered. Methods: We used a Cox proportional hazard model stratified by prior XRT and +/- adjuvant chemo; adjusted for age, gender, synchronous vs metachronous, CMS, MSI and BRAF status. Pts with transverse (T) tumors were excluded in this analysis. Results: Sidedness was determined in 782 pts (L - 472; R - 256; T -54). Molecular data from 728 pts (with L - and R-sided 1°s) was available as follows: KRAS -- 291, NRAS -393, BRAF - 393, MSI - 378, CMS - 533. L vs R mOS: 32.9 v 19.6 months (mo) (p < 0.0001). See Table for OS results in All RAS / BRAF wt and BRAF mutant (mut) pts. Sidedness (R vs L) is an independent prognostic marker even after adjusting for all these molecular features: HR = 1.392 (1.032, 1.878), p = 0.031. Conclusions: Primary tumor location is an independent prognostic factor when adjusted for age, gender, synchronous/metachronous, CMS, MSI and BRAF status. We are exploring clinical variables such as tumor burden, metastatic sites and measurability of disease in an attempt to explain the impact of sidedness. Support: U10CA188021, U10CA180882. Eli Lilly and Co, Genentech/Roche, Pfizer, Sanofi. Clinical trial information: NCT002655850. [Table: see text]

Exploratory analysis of the effect of FTD/TPI in patients treated in RECOURSE by prognostic factors.

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 677-677 ◽  
Author(s):  
Josep Tabernero ◽  
Alberto F. Sobrero ◽  
Christophe Borg ◽  
Atsushi Ohtsu ◽  
Robert J. Mayer ◽  
...  
Keyword(s):  
Liver Metastasis ◽  
Treatment Options ◽  
Progression Free Survival ◽  
Good Prognosis ◽  
Tumor Burden ◽  
Phase Iii ◽  
Kras Status ◽  
Indolent Disease ◽  
Metastatic Sites ◽  
Ecog Ps

677 Background: The Phase III RECOURSE trial, in patients (pts) with metastatic colorectal cancer (mCRC) refractory to standard therapies, demonstrated that trifluridine/tipiracil (FTD/TPI) significantly extended overall survival (OS) and progression-free survival (PFS) versus placebo in all subgroups, regardless of age, geographical origin, or KRAS status, with acceptable safety. Literature reports have shown optimal benefit for pts with low tumor burden (< 3 metastatic sites), indolent disease (≥ 18 mo since diagnosis of first metastasis), ECOG PS 0-1, and no liver metastasis when treated in late line mCRC. Methods: This exploratory post hoc analysis of RECOURSE (all ECOG 0-1) compared pts on FTD/TPI or placebo with good prognostic characteristics (GPC; low tumor burden and indolent disease) and poor prognostic characteristics (PPC; high tumor burden and/or aggressive disease). These subgroups were then analyzed by liver metastasis at baseline, ECOG PS, KRAS status and age. Results: Baseline characteristics were generally similar between the two groups. GPC placebo pts performed better than the PPC placebo pts, but worse than the GPC pts treated with FTD/TPI. GPC pts treated with FTD/TPI showed median OS of 9.3 mo versus 5.3 mo in PPC pts (HR 0.46; 95% CI: 0.37, 0.57; p < 0.0001); there was a similar effect for PFS. GPC pts had significantly better mOS and mPFS regardless of age (≥ 65 vs. < 65 y), ECOG PS (0–1), KRAS status (mutant vs. wildtype), and liver metastasis (y/n). No liver metastasis was the best prognostic factor: mOS in such pts treated with FTD/TPI was 16.4 mo and 7.6 mo in the GPC (n = 97) and PPC (n = 35) groups, respectively (HR 0.42; 95% CI: 0.24, 0.74; p < 0.0019); there was a similar effect for PFS. Pts with ECOG PS 0 at baseline remained PS 0-1 at discontinuation in 96% of the GPC group. Conclusions: Low tumor burden and indolent disease indicate good prognosis in late line mCRC. Pts with no liver metastasis have the best prognosis and are likely to have longer OS. GPCs might explain the percentage of long-term responders on FTD/TPI in RECOURSE. Maintenance of ECOG PS 0–1 during treatment is crucial in the continuum of care, allowing pts to benefit from further treatment options. Clinical trial information: NCT01607957.

Identification of the optimal patients for trifluridine/tipiracil (FTD/TPI) treatment in mCRC: A Spanish real-world analysis.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 146-146
Author(s):  
Ana Fernandez Fernandez Montes ◽  
Francisca Vazquez Rivera ◽  
Nieves Martinez Lago ◽  
Marta Covela Rúa ◽  
Antia Cousillas Castiñeiras ◽  
...  
Keyword(s):  
Liver Metastasis ◽  
Lung Metastases ◽  
Tumor Resection ◽  
Progression Free Survival ◽  
Tumor Stage ◽  
Clinicopathological Characteristics ◽  
Tumor Burden ◽  
Multicenter Observational Study ◽  
Indolent Disease ◽  
Ecog Ps

146 Background: FTD/TPI has demonstrated significantly overall survival (OS) and progression-free survival (PFS) in patients (pts) with metastatic colorectal cancer (mCRC) refractory to standard therapies. Nevertheless, data regarding the pt profile that benefits most from this FTD/TPI is scarce. Some reports have shown optimal benefit for pts with low tumor burden indolent disease, ECOG PS 0-1, and no liver metastasis. Methods: We conducted a retrospective, multicenter, observational study of pts treated with FTD/TPI at eight hospitals from the Galician Research Group on Digestive Tumours (GITuD). Data were analyzed for a correlation between prognostic characteristics (good prognostic characteristics (GPC) vs. poor prognostic characteristics (PPC)), clinicopathological characteristics and survival. The GPC group was composed of pts who have one or two metastatic sites and time from diagnosis of 1st metastases to treatment ≥ 18 months. Results: Between January 1, 2017 and August 20, 2018, 160 pts were included in the study, of which 85 pts (53.1%) were classified as PPC and 75 pts (46.9%), as GPC. Pts with PPC were associated with younger age (60.5 vs. 63.7 years, p=0.034), higher presence of liver metastases (83.5% vs. 60%, p=0.001) and lower incidence of primary tumor resection (34.1% vs. 17.3%, p=0.019), without differences in ECOG PS, RAS mutation, tumor stage at diagnosis, lung metastases and sidedness. In the whole population of pts median OS and PFS were 7.63 months and 2.75 months, respectively. However, in the GPC and PPC groups mPFS were 2.64 vs. 2.33 months, respectively (p=0.311). Also, median OS was 8.23 months for GPC and 6.75 months for PPC, respectively. Interestingly,the mOS reached 10.5 months in those patients in the GPC group without liver metastasis. OS according ECOG PS 0/1/2 were 10.9 vs. 7.8 vs. 4.4 months, respectively (p=0.004) in the GPC group of pts. Conclusions: We have identified a subgroup of pts who most benefit from FTD/TPI, characterized by ECOG PS 0, low tumor burden, indolent disease and no liver metastasis.

Prognostic factors in progressive high-grade glial tumors treated with systemic approach: A single center experience

2020 ◽  
pp. 107815522092068
Author(s):  
Ozkan Alan ◽  
Tugba Akin Telli ◽  
Tugba Basoglu Tuylu ◽  
Rukiye Arikan ◽  
Nazım Can Demircan ◽  
...  
Keyword(s):  
Overall Survival ◽  
Prognostic Factors ◽  
Systemic Treatment ◽  
Progression Free Survival ◽  
High Grade Glioma ◽  
Idh1 Mutation ◽  
High Grade ◽  
Free Survival ◽  
Median Progression Free Survival ◽  
Ecog Ps

Purpose Malignant high-grade gliomas are the most common and aggressive type of primary brain tumor, and the prognosis is generally extremely poor. In this retrospective study, we analyzed the outcome of systemic treatment in recurrent high-grade glioma patients and the impact of prognostic factors on survivals. Methods Data from 114 patients with recurrent high-grade glioma who received systemic treatment and followed in our clinic between 2012 and 2018 were retrospectively analyzed. Eastern Cooperative Oncology Group (ECOG) performance status, age, gender, histology, type of surgical resection, side effects after systemic treatment (deep vein thrombosis, hypertension, proteinuria), IDH1 and alpha thalassemia/mental retardation syndrome X-linked (ATRX) mutation status were investigated as prognostic factors for progression-free survival and overall survival. Results At the time of diagnosis, the median age was 48 (17–77) and 68% of the patients were male. Most common pathologic subtype was glioblastoma multiforme (68%). Median follow-up duration was 9.1 months (1–68 months). Median progression-free survival and overall survival were 6.2 months and 8 months, respectively. In multivariate analysis, ECOG PS, deep venous thrombosis and the presence of ATRX and IDH1 mutation were found to be independent prognostic factors for progression-free survival (p < 0.05) and, ECOG PS, the presence of ATRX and IDH1 mutation for overall survival (p < 0.05). Conclusion Our study is real life data and the median progression-free survival and overall survival rates are similar to the literature. We have found ECOG PS, presence of ATRX and IDH1 mutation to be independent prognostic factors for both progression-free survival and overall survival.

Potential predictive and prognostic factors for sequential treatment with abiraterone acetate and cabazitaxel in metastatic docetaxel-refractory castration-resistant prostate cancer (mDR-CRPC).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e16093-e16093
Author(s):  
Sergio Bracarda ◽  
Alketa Hamzaj ◽  
Michele Sisani ◽  
Giuseppe Di Lorenzo ◽  
Francesca Marrocolo ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Prognostic Factors ◽  
Gleason Score ◽  
Progression Free Survival ◽  
Abiraterone Acetate ◽  
Castration Resistant Prostate Cancer ◽  
Activity Data ◽  
Intention To Treat ◽  
Group 2 ◽  
Ecog Ps

e16093 Background: in recent years Abiraterone Acetate (AA) andCabazitaxel (Cbz) were shown to be efficacious agents in patients with mDR-CRPC. However, no data exist for patients treated with both these drugs in terms of best sequencing evaluation and potential predictive and prognostic factors for different treatment sequencies. Aim of our study was to analyze these data in a real world scenario. Methods: intention-to-treat (ITT) analysis of activity data deriving from all consecutive patients with mDR-CRPC treated in our unit with prednisone plus Cbz, AA or both drugs. Data analyzed were, median Progression Free Survival (mPFS) for the two single agents and their sequencies (evaluated according to PCWG2, Prostate Cancer Working Group 2, criteria) and their possible correlations with median age, Gleason score, baseline PSA, ECOG PS, visceral metastases and number of previous chemotherapy lines. Results: here we report characteristics and activity data of the initial 62 patients, 7 treated with Cbz, 32 with AA and 16 with both drugs. The median age of our study population was 71.5 years (range, 55-87), median Gleason Score 8 (4-9) and median ECOG PS 0 (0–3); visceral disease was present in 37 cases (59.7%). The mPFS, according to Kaplan Meier method (KM), was 4.7 months (m) for patients treated with Cbz, 8.6 months for cases treated with AA and 8.2 m for cases treated with both agents. Of the 16 patients treated with both drugs, 12 received a sequence Cbz-AA and 4 a sequence AA-Cbz for an overall median PFS of, respectively, 5.6 and 4.0 m. Any of the analyzed prognostic or predictive factor was found to be significant. Conclusions: in our experience AA and Cbz were showed to be effective agents in the mDR-CRPC setting also when used sequentially. No clear indication of a preferred treatment sequence was identified such as eventual prognostic/predictive factors, also because of the limited number of treated patients. These data should be analyzed in large size prospective trials.

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