scholarly journals The Clinicopathological Features of BRG1-deficient Non-small Cell Lung Cancer and Its Response to Immunotherapy: A Single-center Retrospective Study

2021 ◽  
Author(s):  
Xiaoyan Chen ◽  
Jing Zhang ◽  
Runze Zhao ◽  
Haimin Xu ◽  
Lei Dong
Keyword(s):  
Disease Control ◽  
Progression Free Survival ◽  
Morphological Diversity ◽  
Disease Control Rate ◽  
Advanced Stage ◽  
Ki 67 ◽  
Inflammatory Infiltration ◽  
Free Survival ◽  
Male Predominance ◽  
Immunohistochemical Markers

Abstract PurposeBRG1-deficient NSCLCs have been more intriguing recently for its highly aggressive clinical behavior and no effective therapies. This study characterized the clinical and pathological features of BRG1-deficient NSCLCs and investigated their response to immunotherapy.MethodsForty-seven cases with BRG1-deficient NSCLC were included. Immunohistochemical markers such as CK7, TTF-1, NapsinA, P40, HepPar-1, Ki-67, BRM, ARID1A and ARID1B were stained. Meanwhile, the PD-L1 expression level, overall survival, progression-free survival and disease control rate of patients received immunotherapy were evaluated.ResultsThis study revealed that: (1) Patients with BRG1-deficient NSCLC have a male predominance(89.4%), smoker enrichment(76.6%) and poor prognosis(median OS: 7.0 months for advanced stage). (2) Histologically, BRG1-deficient NSCLCs presented significant morphological diversity and no lepidic pattern. Inflammatory infiltration and tumor necrosis was a prominent feature. Immunohistochemical analyses showed a distinctive uniform immunophenotype (TTF-1-/NapsinA-/CK7+) in 60.9% (28/46) of cases and HepPar-1 positive in 46.5% (20/43) of cases. BRM loss or significant reduction coexisted in 11.8% (4/34) of cases. No case (0/37) showed loss of ARID1A or ARID1B. (3) For twenty-nine patients with advanced stage, eight patients had received immunotherapy and 4 cases achieved a sustainable clinical response with the disease control rate of 50%. ICIs treated patients had better OS than those who received non-ICIs treatment settings (median OS, 27.0m versus 6.0m, p=0.02). Moreover, patients received ICIs have a median PFS of 17.0 months, while, median PFS on platinum doublet chemotherapy were only 6.0 months(p=0.04). ConclusionBRG1-deficient NSCLC showed diverse histopathological patterns and a unique immunohistochemical phenotype. ICIs–based immunotherapy was a beneficial therapy for BRG1- deficient NSCLC.

scholarly journals Molecular profiling of advanced malignancies guides first-line N-of-1 treatments in the I-PREDICT treatment-naïve study

2021 ◽  
Vol 13 (1) ◽  
Author(s):  
Jason K. Sicklick ◽  
Shumei Kato ◽  
Ryosuke Okamura ◽  
Hitendra Patel ◽  
Mina Nikanjam ◽  
...  
Keyword(s):  
Disease Control ◽  
Progression Free Survival ◽  
Complete Response ◽  
Disease Control Rate ◽  
Unknown Primary ◽  
Combination Therapies ◽  
First Line ◽  
Free Survival ◽  
Treatment Naïve ◽  
Matching Score

Abstract Background Malignancies are molecularly complex and become more resistant with each line of therapy. We hypothesized that offering matched, individualized combination therapies to patients with treatment-naïve, advanced cancers would be feasible and efficacious. Patients with newly diagnosed unresectable/metastatic, poor-prognosis cancers were enrolled in a cross-institutional prospective study. Methods A total of 145 patients were included in the study. Genomic profiling (tissue and/or circulating tumor DNA) was performed in all patients, and PD-L1 immunohistochemistry, tumor mutational burden, and microsatellite status assessment were performed in a subset of patients. We evaluated safety and outcomes: disease-control rate (stable disease for ≥ 6 months or partial or complete response), progression-free survival (PFS), and overall survival (OS). Results Seventy-six of 145 patients (52%) were treated, most commonly for non-colorectal gastrointestinal cancers, carcinomas of unknown primary, and hepatobiliary malignancies (53% women; median age, 63 years). The median number of deleterious genomic alterations per patient was 5 (range, 0–15). Fifty-four treated patients (71%) received ≥ 1 molecularly matched therapy, demonstrating the feasibility of administering molecularly matched therapy. The Matching Score, which reflects the percentage of targeted alterations, correlated linearly with progression-free survival (R2 = 0.92; P = 0.01), and high (≥ 60%) Matching Score was an independent predictor of improved disease control rate [OR 3.31 (95% CI 1.01–10.83), P = 0.048], PFS [HR 0.55 (0.28–1.07), P = 0.08], and OS [HR 0.42 (0.21–0.85), P = 0.02]. Serious adverse event rates were similar in the unmatched and matched groups. Conclusions Personalized combination therapies targeting a majority of a patient’s molecular alterations have antitumor activity as first-line treatment. These findings underscore the feasibility and importance of using tailored N-of-1 combination therapies early in the course of lethal malignancies. Trial registration I-PREDICT (NCT02534675) was registered on August 25, 2015.

scholarly journals Inflammatory Markers Predict Survival in Patients With Advanced Gastric and Colorectal Cancers Receiving Anti–PD-1 Therapy

2021 ◽  
Vol 9 ◽  
Author(s):  
Xiaona Fan ◽  
Dan Wang ◽  
Wenjing Zhang ◽  
Jinshuang Liu ◽  
Chao Liu ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Overall Survival ◽  
Disease Control ◽  
Inflammatory Markers ◽  
Overall Response Rate ◽  
Response Rate ◽  
Progression Free Survival ◽  
Disease Control Rate ◽  
Free Survival ◽  
Lymphocyte Ratio

There is a lack of useful biomarkers for predicting the efficacy of anti–programmed death-1 (PD-1) therapy for advanced gastric and colorectal cancer. To address this issue, in this study we investigated the correlation between inflammatory marker expression and survival in patients with advanced gastric and colorectal cancer. Data for 111 patients with advanced gastric and colorectal cancer treated with anti–PD-1 regimens were retrospectively analyzed. Neutrophil-to-lymphocyte ratio (NLR), monocyte-to-lymphocyte ratio (MLR), platelet-to-lymphocyte ratio (PLR), and clinical characteristics of each patient were selected as the main variables. Overall response rate, disease control rate, and progression-free survival were primary endpoints, and overall survival and immune-related adverse events (irAEs) were secondary endpoints. The chi-squared test and Fisher’s exact test were used to evaluate relationships between categorical variables. Uni- and multivariate Cox regression analyses were performed, and median progression-free survival and overall survival were estimated with the Kaplan–Meier method. The overall response rate and disease control rate of anti–PD-1therapy in advanced gastric and colorectal tumors were 12.61 and 66.66%, respectively. The patients with MLR < 0.31, NLR < 5, and PLR < 135 had a significantly higher disease control rate than those with MLR > 0.31, NLR > 5, and PLR > 135 (P < 0.05). The multivariate analysis revealed that MLR < 0.31, BMI > 18.5, and anti–PD-1 therapy in first-line were associated with prolonged PFS. MLR < 0.31 and BMI > 18.5 were associated with prolonged overall survival. The irAE rate differed significantly between PLR groups, and PLR < 135 was associated with an increased rate of irAEs (P = 0.028). These results indicate that the inflammatory markers NLR, MLR, and PLR have clinical utility for predicting survival or risk of irAEs in patients with advanced gastric cancer and colorectal cancer.

A phase II trial of trastuzumab combined with irinotecan in patients with advanced HER2-positive chemo-refractory gastric cancer: OGSG1203 (HERBIS-5).

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 128-128 ◽  
Author(s):  
Kazuhiro Nishikawa ◽  
Daisuke Sakai ◽  
Junji Kawada ◽  
Ryohei Kawabata ◽  
Tomono Kawase ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Overall Survival ◽  
Disease Control ◽  
Intravenous Infusion ◽  
Response Rate ◽  
Progression Free Survival ◽  
Disease Control Rate ◽  
Efficacy And Safety ◽  
Her2 Positive ◽  
Free Survival

128 Background: Irinotecan is a key drug in second- or further-line chemotherapy for patients with advanced gastric cancer. Continuous administration of trastuzumab beyond first progression is expected to contribute to the benefit of chemotherapy for HER2-positive gastric cancer. We assessed the efficacy and safety of combination chemotherapy with trastuzumab and irinotecan in Japanese patients with advanced HER2-positive chemo-refractory gastric cancer. Methods: Intravenous infusion of irinotecan every 2 weeks at a dose of 150 mg/m2; intravenous infusion of trastuzumab at a dose of 8 mg/kg on day 1 of the first cycle, followed by 6 mg/kg every 3 weeks. Administration of irinotecan and trastuzumab were repeated in independent schedules. The primary endpoint was disease control rate. The secondary endpoints were adverse events, response rate, time-to-treatment failure, progression-free survival, overall survival, and response rate stratified by prior trastuzumab use. This study was conducted by the Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG). Results: From October 2012 to Augst 2014, 30 patients were enrolled and one patient withdrew before study treatment. Accordingly, 29 patients were assessable for efficacy and safety. The disease control rate was 65.5% [95% C.I. 45.7 - 82.1%], and the response rate was 20.7% [95% C.I. 8.0 - 39.7%]. The median progression free survival and the median overall survival were 3.7 and 7.5 months, respectively. The major grade 3/4 toxic effects were neutropenia (24%); anemia (24%); leucopenia (21%); anorexia (11%); fatigue (14%); hypoalbuminemia (24%); and hypokalemia (14%). One death (NOS) was considered to be related to the study. Conclusions: The results of combination Trastuzumab with irinotecan showed feasible and promising efficacy against advanced HER2-positive chemo-refractory gastric cancer. These findings indicated that trastuzumab continuation use might be beneficial. Clinical trial information: 000008626.

Outcomes after retreatment with MAPK inhibitors and immune checkpoint inhibitors in melanoma patients

2021 ◽  
Author(s):  
Oana D Persa ◽  
Cornelia Mauch
Keyword(s):  
Disease Control ◽  
Immune Checkpoint ◽  
Checkpoint Inhibitors ◽  
Univariate Analysis ◽  
Progression Free Survival ◽  
Advanced Melanoma ◽  
Disease Control Rate ◽  
Unknown Primary ◽  
Free Survival ◽  
Mapk Inhibitors

Background: When patients with advanced melanoma progress after MAPK inhibitor (MAPKI) and immune checkpoint inhibitor (ICI) treatment, they can either undergo chemotherapy or rechallenge with previously used treatments. Methods: The outcomes of 48 patients retreated with MAPKIs and 50 patients retreated with ICIs following progression were retrospectively analyzed. Results: Upon retreatment with MAPKIs, the disease control rate was 60%. Univariate analysis of possible risk factors associated with short progression-free survival upon MAPKI treatment showed elevated lactate dehydrogenase to be associated with decreased progression-free survival. Disease control rate after ICI retreatment was 24%. Melanoma of unknown primary was associated with prolonged progression-free survival upon ICI retreatment. Conclusion: Retreatment with MAPKIs or ICIs is a feasible option for patients with advanced melanoma.

scholarly journals A Study of Patient Preferences for the Treatment of Non–small Cell Lung Cancer in Western China: A Discrete-Choice Experiment

2021 ◽  
Vol 9 ◽  
Author(s):  
Fei Liu ◽  
Haiyao Hu ◽  
Jing Wang ◽  
Yingyao Chen ◽  
Sun Hui ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Disease Control ◽  
Discrete Choice Experiment ◽  
Discrete Choice ◽  
Patient Preferences ◽  
Choice Experiment ◽  
Progression Free Survival ◽  
Disease Control Rate ◽  
Free Survival ◽  
Nsclc Patients

Background: Non–small cell lung cancer (NSCLC) is the most common histologic type of lung cancer, accounting for 70–85% of all lung cancers. It has brought a heavy burden of disease and financial cost to families, society, and the nation of China. Patients have differing preferences for treatment because of their varying physical conditions and socioeconomic backgrounds, which ultimately affects the choice of treatment as well as treatment outcomes. For better and sustained health outcomes, it is vital to understand patients' preferences. We can then provide medical services to match these preferences and needs rather than basing treatment on our clinical viewpoints alone.Objectives: The aim of this study was to elicit patient preferences for treatment using a discrete-choice experiment and to explore the value/importance that patients place on the different attributes of treatment in order to provide a basis for clinical decision making and patient health management.Methods: The study was conducted with NSCLC patients from three typical hospitals in southwestern China. After identifying patient-relevant treatment attributes via literature review and qualitative semi structured interviews, a discrete-choice experiment (DCE) including seven patient-relevant attributes was conducted using a fractional factorial SAS design. The empiric data analyses of patients were performed using mixed logit models.Results: NSCLC patients (N = 202) completed a survey via a face-to-face interview. Among the seven attributes, the following were considered important: progression-free survival, disease control rate, cost, weakness/fatigue, and nausea/vomiting; mode of administration and rash were considered less important. A clear preference for an increase in progression-free survival and disease control rate was demonstrated. Compared with 5 months of progression-free survival, respondents were willing to pay more (19,860 RMB) for 11 months of progression-free survival (coef.: 0.687). Compared with a 60% rate of disease control, respondents were willing to pay more (19,940 RMB) for a 90% rate of disease control (coef.: 0.690).Conclusions: This study demonstrates the value of DCEs in determining patient preferences for the treatment of NSCLC. The results indicate that not only efficacy factors (such as progression-free survival and disease control rate) were considered but also other factors (such as side effects and treatment costs) and trade-offs between attributes were held to be important. These results are in accord with expectations and can provide evidence for more effective and efficient treatment results. Furthermore, the current results can increase benefits if the presented therapies can be designed, assessed, and chosen based on patient-oriented findings.

DOCOX: A phase II trial with docetaxel and oxaliplatin as a second-line systemic therapy for patients with advanced and/or metastatic adenocarcinoma of the pancreas.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 4034-4034
Author(s):  
Thomas Jens Ettrich ◽  
Goetz von Wichert ◽  
Thomas M. Gress ◽  
Patrick Michl ◽  
Michael Geissler ◽  
...  
Keyword(s):  
Disease Control ◽  
Phase Ii ◽  
Tumor Response ◽  
Phase Ii Trial ◽  
Systemic Treatment ◽  
Progression Free Survival ◽  
Chemotherapeutic Agents ◽  
Disease Control Rate ◽  
Line Treatment ◽  
Free Survival

4034 Background: In Europe and the USA, pancreatic ductal adenocarcinoma (PDAC) is the fifth most common cause of cancer-related death. For patients with metastatic disease, palliative cytostatic systemic treatment is the only option. There is no established standard for 2nd-line treatment. Fluoropyrimidines either alone or in combination with Oxaliplatin or other chemotherapeutic agents are increasingly used. There are interesting data regarding the combination of Gemcitabine with Oxaliplatin or Docetaxel with respect to progression free survival (PFS) and tumor response in 1st-line. For the first time, the DocOx-trial investigates the combination of Oxaliplatin with Docetaxel as 2nd-line treatment after progression under palliative first-line systemic treatment with Gemcitabine. Methods: Prospective, single arm, non-randomized, multicenter, Simon´s two stage phase II trial using Docetaxel (75 mg/m2, 60 min, d 1) plus Oxaliplatin (80 mg/m2, 120 min, d 2, qd 22). Duration of the trial is scheduled up to 8 cycles. Primary endpoint: tumor response (RR) according to RECIST 1.0. Secondary endpoints: PFS, OS, safety/toxicity, QoL/clinical benefit. Results: Here we present the data on response rate (RR), median progression free survival (mPFS) and median overall survival (mOS) as of February 4th, 2013. Data represents the Intention to treat-analysis of the 44 patients included between 2009 and 2012. 5 patients did not obtain any treatment. RR was 16% (7 partial remissions, no complete remission) with a disease control rate (DCR) of 48% after the first two treatment cycles. Median PFS was 7 weeks ( 95%-CI: 6-16 w.) and median OS after start of 2nd-line therapy was 36 weeks ( 95%-CI: 19-55 w.). Conclusions: In this single-arm 2nd-line trial for the treatment of PDAC, the combination of Doxcetaxel and Oxaliplatin shows very promising results compared to other 2nd-line-protocols such as OFF. Some patients seem to benefit particularly as indicated by long periods of treatment in this setting. Even after 8 cycles of treatment with DocOx, partial response was observed in 2 patients and stable disease in another 6 patients corresponding a disease control rate of 18%. Clinical trial information: NCT00690300.

The impact of dose reduction and time delay in irinotecan- and oxaliplatin-based chemotherapies on outcomes in metastatic colorectal cancer.

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 631-631
Author(s):  
Naoki Mashita ◽  
Goro Nakayama ◽  
Naomi Hayashi ◽  
Chie Tanaka ◽  
Daisuke Kobayashi ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Time Delay ◽  
Disease Control ◽  
Metastatic Colorectal Cancer ◽  
Total Dose ◽  
Dose Reduction ◽  
Response Rate ◽  
Progression Free Survival ◽  
Disease Control Rate ◽  
Free Survival

631 Background: This study was designed to evaluate the influence of dose reduction and schedule modification on outcomes in patients with metastatic colorectal cancer (mCRC). Methods: Pooled datasets from two previous phase II trials of FOLFIRI (CCOG-0502; n = 36) and mFOLFOX6 (CCOG-0704; n = 30) in patients with mCRC were analyzed retrospectively. The RDIs of irinotecan and oxaliplatin were compared to response rate (RR), disease control rate (DCR), progression-free survival (PFS) and overall survival (OS). To assess the effects of dose reduction and time delay, we defined ‘dose index (DI)’ as the ratio of the actual delivered total dose to the planned total dose and ‘time index (TI)’ as the ratio of the planned duration to the actual duration of therapy. Relative dose intensity (RDI) was computed by multiplying DI by TI. DI and TI of irinotecan and oxaliplatin were compared to response rate (RR), disease control rate (DCR) and progression-free survival (PFS). Results: In patients receiving FOLFIRI therapy, the median DI and TI of irinotecan were 0.92 and 0.90, respectively. RRs were 59% vs. 12% in the higher vs. lower DI groups (p < 0.01), and 35% vs. 35% in the higher vs. lower TI groups (p = 1.00), respectively. Median PFS was 10.2 vs. 5.0 months in the higher vs. lower DI groups (p < 0.01), and 6.1 vs. 6.7 months in the higher vs. lower TI groups (p = 0.48), respectively. In mFOLFOX6 therapy, the median DI and TI of oxaliplatin were 0.97 and 0.82, respectively. RRs were 44% vs. 36% in the higher vs. lower DI groups (p = 0.65), and 44% vs. 36% in the higher vs. lower TI groups (p = 0.65), respectively. Median PFS was 7.7 vs. 6.7 months in the higher vs. lower DI groups (p = 0.13), and 8.5 vs. 5.9 months in the higher vs. lower TI groups (p = 0.02), respectively. Multivariate analyses showed that DI of irinotecan (HR 8.48; 95% CI, 2.94-24.51, p < 0.01) and TI of oxaliplatin (HR 2.74; 95% CI, 1.02-7.33, p = 0.04) were the independent prognostic factors for PFS. Conclusions: Dose reductions in irinotecan and time delays in oxaliplatin could have significant impact on PFS in patients receiving FOLFIRI and FOLFOX6, respectively.

Apatinib monotherapy for chemotherapy-refractory metastatic colorectal cancer: A multicenter, single-arm, prospective study.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 3527-3527 ◽  
Author(s):  
Fen Wang ◽  
Shubin Wang ◽  
Xia Yuan ◽  
Jun Jia ◽  
Xiaoxia Bi ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Overall Survival ◽  
Prospective Study ◽  
Disease Control ◽  
Metastatic Colorectal Cancer ◽  
Response Rate ◽  
Objective Response ◽  
Progression Free Survival ◽  
Disease Control Rate ◽  
Free Survival

3527 Background: Apatinib is an oral highly-selective tyrosine kinase inhibitor (TKI) that blocks vascular endothelial growth factor receptor 2 (VEGFR-2). This exploratory study evaluated the efficacy and safety of apatinib monotherapy in patients with chemotherapy-refractory metastatic colorectal cancer. Methods: In this multicenter, single-arm, prospective study, 48 patients with metastatic colorectal cancer who had failed at least two lines standard chemotherapies including fluorouracil, oxaliplatin and irinotecan were recruited from 14 centers in Guangdong, China. Apatinib at a 500mg dose was administered daily continuously. Each cycle was 4 weeks (28 days). The primary endpoint was progression free survival (PFS). Secondary end points included overall survival (OS), objective response rate (ORR), disease control rate (DCR), quality of life (QoL) and toxicity. Results: A total of 48 patients was enrolled in the study from September 3, 2015 to June9, 2017. Four patients achieved a partial response, and 22 achieved stable disease, representing a response rate of 8.3% and a disease control rate of 60.4%. Median follow-up time was 10.3 months. Median progression-free survival (PFS) and overall survival (OS) of evaluable patients (n=41) were 4.7 months (95% confidence interval [CI] 3.7-5.9) and 9.7 months (95% CI 5.9-13.6). The most common grade 3 or 4 adverse events (AE) were hypertension (12.5%), hand-foot syndrome (10.4%), thrombocytopenia (10.4%), proteinuria (8.3%) and mucositis oral (6.3%). Conclusions: Apatinib monotherapy shows promising efficacy and manageable toxicities in patients with chemotherapy-refractory metastatic colorectal cancer. Further phase 3 trial is warranted. Clinical trial information: ChiCTR1900020503.

Strahlentherapie bei Chemotherapie-refraktärem rezidivierendem Ovarialkarzinom

2015 ◽  
Vol 2 (1) ◽  
pp. 30-31
Keyword(s):  
Overall Survival ◽  
Disease Control ◽  
Response Rate ◽  
Progression Free Survival ◽  
Disease Control Rate ◽  
Palliative Behandlung ◽  
Unerwünschte Ereignisse ◽  
Free Survival ◽  
Schwerwiegende Unerwünschte Ereignisse

Ziele: Die Strahlentherapie ist als palliative Behandlung bei rezidivierendem Ovarialkarzinom gebräuchlich, jedoch wurde bisher nicht geklärt, ob sie die Prognose verbessert.Methoden: Die Wirkung einer Strahlentherapie und die damit einhergehenden unerwünschten Ereignisse bei Patientinnen mit rezidivierendem Ovarialkarzinom wurden anhand deren Patientenakten untersucht.Ergebnisse: Hierbei wurden 46 Patientinnen betrachtet: 33 Patientinnen, deren rezidivierende Läsionen auf das Bestrahlungsfeld begrenzt waren (therapeutische Bestrahlungsgruppe; TBG), und 13 Patientinnen, bei denen die rezidivierenden Läsionen zum Teil außerhalb des Bestrahlungsfelds lagen (palliative Bestrahlungsgruppe; PBG). In der TBG betrug die Ansprechrate (response rate; RR) 66%, die Rate der Krankheitsbeherrschung (disease control rate; DCR) 100%, das progressionsfreie Überleben (progression-free survival; PFS) 10 Monate und das Gesamtüberleben (overall survival; OS) 20 Monate. Das PFS nach Bestrahlung war signifikant länger als nach Bestrahlung mit unmittelbar vorausgehender Chemotherapie. Das PFS der Patientinnen mit Rezidivläsionen innerhalb des Beckens war länger als bei den Patientinnen, deren Läsionen zum Teil außerhalb des Beckens lagen. Zwischen dem PFS nach Strahlentherapie und der Dauer seit der vorhergehenden Chemotherapie oder dem histologischen Typ bestand kein signifikanter Zusammenhang. In der PBG lagen die RR bei 30%, die DCR bei 90%, das PFS bei 2 Monaten und das OS bei 6 Monaten. Schwerwiegende unerwünschte Ereignisse traten selten auf.Schlussfolgerungen: Bestrahlung ist eine mögliche Option bei Chemotherapie-refraktärem, lokal begrenztem rezidivierendem Ovarialkarzinom.Übersetzung aus Oncology 2014;86:232-238 (DOI: 10.1159/000357269)

Nab-paclitaxel as second-line treatment in advanced biliary cancer.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 463-463
Author(s):  
Gerald W. Prager ◽  
Gabriela Kornek ◽  
Werner Scheithauer ◽  
Guenther G. Steger ◽  
Christoph Zielinski ◽  
...  
Keyword(s):  
Overall Survival ◽  
Disease Control ◽  
Progression Free Survival ◽  
Disease Control Rate ◽  
Phase Iii ◽  
Biliary Cancer ◽  
Line Treatment ◽  
Second Line ◽  
Free Survival ◽  
Paclitaxel Treatment

463 Background: Addition of nab-paclitaxel to gemcitabine has recently been demonstrated in the clinical phase III trial MPACT to be beneficial for progression free survival, overall response rate, and overall survival in advanced pancreatic cancer patients. Any potential biologic activity of nab-paclitaxel in biliary cancer is hitherto unknown. Methods: A retrospective analysis of patients with advanced biliary cancer was undertaken to determine the disease control rate (CR+PR+SD), progression-free survival and overall survival in patients who had received nab-paclitaxel-based chemotherapy after failure of a platinum-containing first-line combination chemotherapy. Results: Eleven patients were identified. 4 of 11 patients received nab-paclitaxel as second line, 7 of 11 patients as a third-line treatment. 7 of 11 patients received nab-paclitaxel in combination with gemcitabine, while in 4 of 11 patients nab-paclitaxel was combined with fluoropyrimidine. The disease control rate seen with nab-paclitaxel was 81% (nine of eleven patients). Disease was progressive in one patient, and in one patient the response status is unknown yet. One patient received partial remission and 8 patients had stable disease. As of September 13th, 2014, three patients are still undergoing nab-paclitaxel combination therapy, but were censored by this date for analysis. The median time to progression was 4.9 months (2.3 – 18.9 months) for all patients (11/11 pts.), and 9.5 months for patients completed nab-paclitaxel treatment (8/11 pts.). Median overall survival for all eleven patients after initiation of nab-paclitaxel treatment was 7.3 month (2.6 – 21.8 month). The mean time of survival after diagnosis of advanced disease was 21.3 month, whereby 5 patients were alive at date of censoring. Conclusions: Nab-paclitaxel based chemotherapy can be an effective second-line regimen after platinum-failure in patients with advanced biliary cancer. In this small series, nab-paclitaxel appears to have a biological activity by controlling the disease and positively affecting survival. Randomized trials in this group of patients are urged.

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