Phase II multicenter study of antroquinonol in patients with stage IV non-small cell lung cancer who have failed at least two lines of anti-cancer therapy.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e20522-e20522
Author(s):  
Ching-Liang Ho ◽  
David S. Ettinger ◽  
Pei-Ni Chen ◽  
Howard Cheng ◽  
Wu-Che Wen ◽  
...  
Keyword(s):  
Overall Survival ◽  
Cancer Therapy ◽  
Confidence Interval ◽  
Disease Control ◽  
Stage Iv ◽  
Progression Free Survival ◽  
Disease Control Rate ◽  
Free Survival ◽  
Prior Chemotherapy ◽  
Anti Cancer

e20522 Background: The aim of this study was to assess the efficacy of Antroquinonol in patients with stage IV NSCLC after failure in two-lines of anti-cancer therapy. Methods: Patients with stage IV non-squamous NSCLC who have failed at 2-4 lines of anti-cancer therapy were eligible, though early stage or naïve patients may voluntarily participate. A maximum of 30 evaluable patients were to receive Antroquinonol 600mg per day, of which 15 patients were to be KRAS-positive and 15 patients KRAS negative. The primary endpoint of the study was progression-free survival from the start of treatment to week 12 with disease control rate and overall survival as key secondary endpoints. Results: There were 31 patients enrolled with evaluable population 30 patients, of which 15 patients were KRAS positive and 15 patients KRAS negative. 73% were with at least two prior chemotherapy. The median PFS of 7 patients with 2 prior chemotherapy was 22.9 weeks (95% confidence interval [CI]: 5.0, 31.1); and 11 patients with more than 2 prior chemotherapy was 11.9 weeks (95% confidence interval [CI]: 6.0, 14.1), with a 1-year PFS of 11.4%. Of 11 patients who had had more than 2 prior chemotherapy, the median OS was 47.3 weeks (95% CI: 14.1,-), with a 1-year OS of 39.3%, and the overall disease control rate was 72.7%, with 100% in KRAS negative and 50% in KRAS positive. No systemic toxicities were observed. Conclusions: The monotherapy of Antroquinonol brought up higher disease control rates and longer progression-free survival and overall survival, compared with historical data. Although KRAS negative shows much better than KRAS positive group, Antroquinonol still work well with KRAS positive patients. Clinical trial information: NCT02047344.

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.

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.

Phase II Study of Docetaxel Weekly in Combination With Carboplatin Every 3 Weeks as First-Line Chemotherapy in Stage IIB to Stage IV Epithelial Ovarian Cancer

2012 ◽  
Vol 22 (1) ◽  
pp. 47-53 ◽  
Author(s):  
Bengt Sorbe ◽  
Marianne Graflund ◽  
György Horvath ◽  
Marie Swahn ◽  
Karin Boman ◽  
...  
Keyword(s):  
Overall Survival ◽  
Confidence Interval ◽  
Ovarian Carcinoma ◽  
Response Rate ◽  
Stage Iv ◽  
Progression Free Survival ◽  
Clinical Response Rate ◽  
Hematologic Toxicity ◽  
First Line ◽  
Free Survival

ObjectivesThe purpose of this study was to assess the response rate, toxicity, progression-free survival, and overall survival in a series of patients with advanced-stage ovarian carcinoma treated with a first-line weekly docetaxel and 3 weekly carboplatin regimen.MethodsAll eligible patients were treated with intravenous docetaxel (30 mg/m2) on days 1, 8, and 15, and carboplatin (area under the curve, 5) on day 1; every 21 days for at least 6 cycles.ResultsOne hundred six patients received at least one cycle of primary chemotherapy (median, 6.0; range, 1–9), and they were evaluable for toxicity assessment. Eighty-five patients had evaluable (measurable) disease and received at least 3 courses of chemotherapy and were evaluable for clinical response rate. The overall response rate was 78.8% (95% confidence interval, 70.1%–87.5%), and the biochemical response 92.8% (95% confidence interval, 87.2%–98.4%). The median progression-free survival was 12.0 months and the median overall survival was 35.3 months. Thirty-six patients (34.0%) experienced grades 3 and 4 neutropenia, which resulted in the removal of 3 patients. Six patients (5.7%) experienced grades 3 or 4 thrombocytopenia. No patients experienced grade 3 to grade 4 sensory neuropathy. Epiphora, nail changes, and fatigue were frequently recorded nonhematologic adverse effects.ConclusionsThe tolerable hematologic toxicity (no need for colony-stimulating factors) and the low rate of neurotoxicity (only grades 1–2) and response rates in line with the standard 3-week paclitaxel-carboplatin regimen for advanced primary ovarian carcinoma after suboptimal cytoreductive surgery make this regimen an interesting alternative in selected patients.

scholarly journals The Prognostic Value of Circulating Tumor Cells in Asian Neuroendocrine Tumors

2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Jason Chia-Hsun Hsieh ◽  
Guan-Yu Chen ◽  
David Da-Wei Jhou ◽  
Wen-Chi Chou ◽  
Chun-Nan Yeh ◽  
...  
Keyword(s):  
Overall Survival ◽  
Cancer Therapy ◽  
Tumor Cells ◽  
Neuroendocrine Tumors ◽  
Chromogranin A ◽  
Prognostic Value ◽  
Progression Free Survival ◽  
Free Survival ◽  
Kaplan Meier ◽  
Anti Cancer

AbstractCirculating tumor cells (CTC) play important roles in various cancers; however, few studies have assessed their clinical utility in neuroendocrine tumors. This study aimed to prospectively evaluate the prognostic value of CTC counts in Asian patients with neuroendocrine tumors before and during anti-cancer therapy. Patients who were diagnosed with unresectable histological neuroendocrine tumors between September 2011 and September 2017 were enrolled. CTC testing was performed before and during anti-cancer therapy using a negative selection protocol. Chromogranin A levels were also assessed. Univariate and multivariate Cox’s proportional hazard model with forward LR model was performed to investigate the impact of independent factors on overall survival and progression-free survival. Kaplan–Meier method with log-rank tests were used to determine the difference among different clinicopathological signatures and CTC cutoff. The baseline CTC detection rate was 94.3% (33/35). CTC counts were associated with cancer stages (I-III vs. IV, P = 0.015), liver metastasis (P = 0.026), and neuroendocrine tumor grading (P = 0.03). The median progression-free survival and overall survivals were 12.3 and 30.4 months, respectively. In multivariate Cox regression model, neuroendocrine tumors grading and baseline CTC counts were both independent prognostic factors for progression-free survival (PFS, P = 0.005 and 0.015, respectively) and overall survival (OS, P = 0.018 and 0.023, respectively). In Kaplan-Meier analysis, lower baseline chromogranin A levels were associated with longer PFS (P = 0.024). Baseline CTC counts are associated with the clinicopathologic features of neuroendocrine tumors and are an independent prognostic factor for this malignancy.

scholarly journals Phase II study of lenvatinib for metastatic colorectal cancer refractory to standard chemotherapy: the LEMON study (NCCH1503)

ESMO Open ◽  
2020 ◽  
Vol 5 (4) ◽  
pp. e000776 ◽  
Author(s):  
Satoru Iwasa ◽  
Natsuko Okita ◽  
Aya Kuchiba ◽  
Gakuto Ogawa ◽  
Mamiko Kawasaki ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Overall Survival ◽  
Growth Factor ◽  
Disease Control ◽  
Metastatic Colorectal Cancer ◽  
Growth Factor Receptor ◽  
Progression Free Survival ◽  
Disease Control Rate ◽  
Vegf Receptor ◽  
Free Survival

BackgroundLenvatinib inhibits tyrosine kinases, including vascular endothelial growth factor (VEGF) receptor, fibroblast growth factor receptor, platelet-derived growth factor receptor alpha, RET proto-oncogene and KIT proto-oncogene, receptor tyrosine kinase. We assessed the efficacy and safety of lenvatinib in patients with metastatic colorectal cancer after failure of standard chemotherapies.Patients and methodsThis was an open-label, single centre, single-arm, phase 2 study. Eligible patients had unresectable metastatic colorectal adenocarcinoma, refractory or intolerant to fluoropyrimidine, irinotecan, oxaliplatin, trifluridine/tipiracil, anti-VEGF therapy and anti-epidermal growth factor receptor therapy (for tumours with wild-type RAS). Patients were treated with oral lenvatinib at 24 mg one time a day in 28-day cycles until disease progression or unacceptable toxicity. The primary endpoint was centrally assessed disease control rate. Secondary endpoints included safety, response rate, progression-free survival and overall survival. The planned sample size was 30 patients to expect a disease control rate of 60% with a threshold disease control rate of 35%, one-sided alpha of 5% and power of 80%ResultsBetween 24 October 2016 and 23 January 2018, 30 patients were enrolled; 11 (37%) and 19 (63%) had received 3 or ≥4 lines of prior chemotherapy for metastatic disease, respectively. The median number of lenvatinib cycles was 4 (range 1–13). The centrally assessed disease control rate was 70.0% (21/30, 90% CI 53.5% to 83.4%, one-sided p=0.0001); 2 patients had a partial response and 19 had a stable disease. Median progression-free survival was 3.6 months (95% CI 2.6 to 3.7). Median overall survival was 7.4 months (95% CI 6.4 to 10.8). The most common grade ≥3 adverse events were hypertension (53%), thrombocytopenia (10%), increased alanine aminotransferase and anorexia (7% each).ConclusionsLenvatinib showed promising clinical activity and was tolerated in patients with metastatic colorectal cancer after failure of standard chemotherapies.Trial registration numberUMIN-CTR, UMIN000023446 and JAMCCT-CTR, JMA-IIA00261.

A Phase 2, Randomized, Open-Label Study of Irosustat Versus Megestrol Acetate in Advanced Endometrial Cancer

2017 ◽  
Vol 27 (2) ◽  
pp. 258-266 ◽  
Author(s):  
Patricia Pautier ◽  
Ignace Vergote ◽  
Florence Joly ◽  
Bohuslav Melichar ◽  
Elzbieta Kutarska ◽  
...  
Keyword(s):  
Overall Survival ◽  
Endometrial Cancer ◽  
Adverse Events ◽  
Confidence Interval ◽  
Progression Free Survival ◽  
Megestrol Acetate ◽  
Phase 2 ◽  
Open Label ◽  
Free Survival ◽  
Recurrent Endometrial Cancer

ObjectiveAdvanced/metastatic or recurrent endometrial cancer has a poor prognosis. Malignant endometrial tissue has high steroid sulphatase (STS) activity. The aim of this study was to evaluate STS as a therapeutic target in patients with endometrial cancer.MethodsThis was a phase 2, multicenter, international, open-label, randomized (1:1), 2-arm study of the STS inhibitor oral irosustat 40 mg/d versus oral megestrol acetate 160 mg/d in women with advanced/metastatic or recurrent estrogen receptor–positive endometrial cancer. The primary end point was the proportion of patients without progression or death 6 months after start of treatment. Secondary end points included progression-free survival, time to progression, overall survival, and safety.ResultsSeventy-one patients were treated (36 with irosustat, 35 with megestrol acetate). The study was prematurely stopped after futility analysis. Overall, 36.1% and 54.1% of patients receiving irosustat or megestrol acetate had not progressed or died at 6 months, respectively. There were no statistically significant differences between irosustat and megestrol acetate in response and overall survival rates. Irosustat patients had a median progression-free survival of 16 weeks (90% confidence interval, 9.0–31.4) versus 40 weeks (90% confidence interval, 16.3–64.0) in megestrol acetate patients. Treatment-related adverse events occurred in 20 (55.6%) and 13 (37.1%) patients receiving irosustat or megestrol, respectively. Most adverse events in both groups were grade 1 or 2.ConclusionsAlthough irosustat monotherapy did not attain a level of activity sufficient for further development in patients with advanced/recurrent endometrial cancer, this study confirms the activity of hormonal treatment (megestrol acetate) for this indication.

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