Impact of decision-support system and guideline treatment concordance on response rate in advanced lung cancer.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e20006-e20006
Author(s):  
Jun Liang ◽  
Chuanhao Tang ◽  
Xiangyi Wang ◽  
Ziwei Guo ◽  
Jun Ni ◽  
...  
Keyword(s):  
Decision Support ◽  
Response Rate ◽  
Objective Response ◽  
Stage Iv ◽  
Clinical Decision Support Systems ◽  
Complete Response ◽  
Therapeutic Options ◽  
Advanced Lung Cancer ◽  
Chinese Society ◽  
Cross Sectional

e20006 Background: Clinical decision-support systems (CDSS) provide up-to-date evidence to practitioners overwhelmed by the deluge of clinical findings. Few studies, however, have evaluated their impact on patient outcomes. This cross-sectional retrospective study was conducted to: 1) measure concordance of real-world clinical decisions with therapeutic options from the IBM Watson for Oncology (WfO) CDSS and the Chinese Society of Clinical Oncology (CSCO) guidelines, 2) the effect of concordance on objective response rate (ORR). Methods: Health records from patients receiving 1stline treatment at Peking University International Hospital Oncology Center in China between January 2016 and December 2018 (69 stage IV NSCLC, 30 with SCLC) with documented tumor progression after 2+ cycles of treatment, were reviewed to determine concordance of actual treatment with WfO therapeutic options and CSCO guidelines. Patients’ treatments were grouped as concordant with: WfO+CSCO, WFO only, CSCO only, or neither. ORR, defined as partial or complete response after 2+ treatment cycles (RECIST criteria)was determined for each group. Results: For NSCLC, ORR ranged from 21.4% for discordance with both WfO and CSCO to 100.0% for WfO only concordance. For SCLC, ORR ranged from 37.5% for CSCO only concordance to 73.3% for WfO+CSCO concordance (Table). The main reasons for discordance were: 1stgeneration TKIs like Gefitinib and Erlotinib (vs. Osimertinib) are standard of care for EGFR mutant patients in China, (2) Local CSCO guideline drugs like Lobaplatin and Icotinib are not included in WfO. Conclusions: This study provides preliminary evidence to suggest that treatment concordance with WfO may be associated with improved ORR in some cases of NSCLC (WfO only) and SCLC (WfO + CSCO). ORR in NSCLC patients who were discordant with both WFO and CSCO guidelines was the lowest at 21.4%. Larger studies are needed to understand the effect of guideline and WfO concordance on ORR. [Table: see text]

Arterial blood carboxyhemoglobin as a predictor for response after chemotherapy in patients with lung cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 20029-20029
Author(s):  
K. Nakayama ◽  
H. Yasuda ◽  
T. Sasaki ◽  
T. Suzuki ◽  
M. Asada ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Progressive Disease ◽  
Response Rate ◽  
Stage Iv ◽  
Complete Response ◽  
Chemotherapy Cycle ◽  
Advanced Lung Cancer ◽  
Cancer Tissue ◽  
Arterial Blood ◽  
Response To Chemotherapy

20029 Background: It is desirable to predict the response to chemotherapy in patients with lung cancer using a simple and reliable method. Arterial blood carboxyhemoglobin concentration (Hb-CO) is a useful biomarker for severity in inflammatory pulmonary diseases and is associated with cancer tissue volume in operable NSCLC. However, arterial Hb-CO as a predictor for response to chemotherapy in advanced lung cancer has not been reported. Methods: We enrolled 35 patients with SCLC and 66 ones with NSCLC in stage III or stage IV, treated with chemotherapy between October 2000 and December 2002. All patients with SCLC were treated with PE (cisplatin 80 mg/m2, day 1 and etoposide 100 mg/m2, day 1-day 3) every 3 weeks. The patients with NSCLC were treated with either VC (vinorelbine 25 mg/m2, day 1 and 8 plus cisplatin 80 mg/m2, day 1) or DG (gemcitabine 1100 mg/m2, day 1 and day 8 plus docetaxel 60 mg/m2, day 1) every 3 weeks. Arterial Hb-CO were examined before and at during chemotherapy and the response rate were studied. The patients with either a partial response (PR) or a complete response (CR) were categorized as responder, whereas patients with no change (NC) or progressive disease (PD) were as non-responders. According to the analysis in aterial Hb-CO, the patients were divided into two subgroups, patients with high (≥0.3%) or low (<0.3%) maximum changes in the Hb-CO (ΔHb-CO) during chemotherapy. Results: The response rate was 80% in SCLC and 38% in NSCLC. In responder patients with SCLC or NSCLC, the arterial Hb-CO significantly increased and reached maximum at day 4 of the 1st cycle of chemotherapy. In contrast, in non-responder patients, the Hb-CO did not increase during the chemotherapy. The response rate in patients with high ΔHb-CO was significantly higher than that with low ΔHb-CO in SCLC (26/26 vs 2/9, P < .001) and NSCLC (24/24 vs 1/42, P < .001). The high ΔHb-CO at day 4 of the 1st chemotherapy cycle was significantly associated with the response to the chemotherapy in SCLC (Odd ratio, OR = 12.5 [95% CI: 3.13–50, P < .001]) and in NSCLC (OR = 25 [95% CI: 3.23–100, P < .01]) (logistic regression analysis). Conclusions: Increases in arterial Hb-CO at day 4 of the 1st chemotherapy cycle in SCLC and SCLC may be a predictor of response to chemotherapy. No significant financial relationships to disclose.

Phase II clinical trial with a second generation, GM-CSF encoding, oncolytic herpesvirus in unresectable metastatic melanoma

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 9035-9035 ◽  
Author(s):  
N. N. Senzer ◽  
H. Kaufman ◽  
T. Amatruda ◽  
M. Nemunaitis ◽  
G. Daniels ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Metastatic Melanoma ◽  
Phase Ii ◽  
Response Rate ◽  
Objective Response ◽  
Stage Iv ◽  
Complete Response ◽  
Phase Iii ◽  
Stage Iiic ◽  
Gm Csf

9035 Background: OncoVEXGM-CSF is a an oncolytic HSV, encoding GM-CSF . We recently completed a phase II trial involving 50 advanced melanoma patients (stage IIIc and IV) with at least one injection accessible lesion, including by ultrasound. Methods: Patients received a single IT injection of 106 pfu/ml apportioned between 10 or less injectable tumors, followed 3 wks later by 24 or less sequential injections of 108 pfu/ml every 2 wks until clinically significant disease progression, or overall or injectable lesion complete response. Response (RECIST modified to allow progression before response and biopsy of residual masses) and survival were monitored. Results: All 50 pts have been enrolled and are evaluable (Stage IIIc, n=10; IV M1a, n=16; IV M1b, n=4; IV M1c, n=20). A median of 6 injections were administered. Adverse effects were limited and generally involved transient flu-like symptoms. Both injected and uninjected regional and distant disease demonstrated response including clearly documented responses at uninjected visceral sites. The overall response rate was 26% (8 CR, 5 PR); 10 responses have been maintained for >6 months and 2 are ongoing at <6months, the longest currently being at 35 months from first dose. 93% of patients (14 of 15) with PR, CR or surgical CR remain alive. Ten additional patients had SD for >3 months. Kaplan Meier one year survival is 61% overall, 58% stage IV only, 48% for Stage IV M1c. The median OS is 16+ months. Conclusions: The 1-year survival and durable objective response rate are encouraging. Responses of distant and visceral disease provide further compelling evidence of systemic effectiveness. This, combined with a limited toxicity profile, suggests OncoVEXGM-CSF is a promising treatment for metastatic melanoma. A phase III clinical trial is planned. [Table: see text]

scholarly journals Comparison of an oncology clinical decision-support system’s recommendations with actual treatment decisions

2021 ◽  
Author(s):  
Suthida Suwanvecho ◽  
Harit Suwanrusme ◽  
Tanawat Jirakulaporn ◽  
Surasit Issarachai ◽  
Nimit Taechakraichana ◽  
...  
Keyword(s):  
Decision Support ◽  
Clinical Decision Support ◽  
Treatment Options ◽  
Stage Iv ◽  
Clinical Decision ◽  
Treatment Decisions ◽  
Therapeutic Options ◽  
Cancer Type ◽  
The Us ◽  
Rectal Cancers

Abstract Objective IBM(R) Watson for Oncology (WfO) is a clinical decision-support system (CDSS) that provides evidence-informed therapeutic options to cancer-treating clinicians. A panel of experienced oncologists compared CDSS treatment options to treatment decisions made by clinicians to characterize the quality of CDSS therapeutic options and decisions made in practice. Methods This study included patients treated between 1/2017 and 7/2018 for breast, colon, lung, and rectal cancers at Bumrungrad International Hospital (BIH), Thailand. Treatments selected by clinicians were paired with therapeutic options presented by the CDSS and coded to mask the origin of options presented. The panel rated the acceptability of each treatment in the pair by consensus, with acceptability defined as compliant with BIH’s institutional practices. Descriptive statistics characterized the study population and treatment-decision evaluations by cancer type and stage. Results Nearly 60% (187) of 313 treatment pairs for breast, lung, colon, and rectal cancers were identical or equally acceptable, with 70% (219) of WfO therapeutic options identical to, or acceptable alternatives to, BIH therapy. In 30% of cases (94), 1 or both treatment options were rated as unacceptable. Of 32 cases where both WfO and BIH options were acceptable, WfO was preferred in 18 cases and BIH in 14 cases. Colorectal cancers exhibited the highest proportion of identical or equally acceptable treatments; stage IV cancers demonstrated the lowest. Conclusion This study demonstrates that a system designed in the US to support, rather than replace, cancer-treating clinicians provides therapeutic options which are generally consistent with recommendations from oncologists outside the US.

Massive transfusion experience, current practice and decision support: A survey of Australian and New Zealand anaesthetists

2021 ◽  
pp. 0310057X2097403
Author(s):  
Brenton J Sanderson ◽  
Jeremy D Field ◽  
Lise J Estcourt ◽  
Erica M Wood ◽  
Enrico W Coiera
Keyword(s):  
Decision Support ◽  
Decision Support System ◽  
Clinical Decision Support ◽  
Support System ◽  
Clinical Decision Support System ◽  
Response Rate ◽  
Massive Transfusion ◽  
Clinical Decision Support Systems ◽  
Clinical Decision ◽  
Transfusion Practice

Massive transfusions guided by massive transfusion protocols are commonly used to manage critical bleeding, when the patient is at significant risk of morbidity and mortality, and multiple timely decisions must be made by clinicians. Clinical decision support systems are increasingly used to provide patient-specific recommendations by comparing patient information to a knowledge base, and have been shown to improve patient outcomes. To investigate current massive transfusion practice and the experiences and attitudes of anaesthetists towards massive transfusion and clinical decision support systems, we anonymously surveyed 1000 anaesthetists and anaesthesia trainees across Australia and New Zealand. A total of 228 surveys (23.6%) were successfully completed and 227 were analysed for a 23.3% response rate. Most respondents were involved in massive transfusions infrequently (88.1% managed five or fewer massive transfusion protocols per year) and worked at hospitals which have massive transfusion protocols (89.4%). Massive transfusion management was predominantly limited by timely access to point-of-care coagulation assessment and by competition with other tasks, with trainees reporting more significant limitations compared to specialists. The majority of respondents reported that they were likely, or very likely, both to use (73.1%) and to trust (85%) a clinical decision support system for massive transfusions, with no significant difference between anaesthesia trainees and specialists ( P = 0.375 and P = 0.73, respectively). While the response rate to our survey was poor, there was still a wide range of massive transfusion experience among respondents, with multiple subjective factors identified limiting massive transfusion practice. We identified several potential design features and barriers to implementation to assist with the future development of a clinical decision support system for massive transfusion, and overall wide support for a clinical decision support system for massive transfusion among respondents.

Phase II Randomized Trial of Temozolomide and Concurrent Radiotherapy in Patients With Brain Metastases

2002 ◽  
Vol 20 (17) ◽  
pp. 3644-3650 ◽  
Author(s):  
D. Antonadou ◽  
M. Paraskevaidis ◽  
G. Sarris ◽  
N. Coliarakis ◽  
I. Economou ◽  
...  
Keyword(s):  
Brain Metastases ◽  
Randomized Trial ◽  
Response Rate ◽  
External Beam Radiotherapy ◽  
Objective Response ◽  
Complete Response ◽  
Hematologic Toxicity ◽  
Neurologic Symptom ◽  
Symptom Evaluation ◽  
Radiotherapy Alone

PURPOSE: To determine the efficacy, tolerability, and safety of concurrent temozolomide and radiotherapy in patients with previously untreated brain metastases. PATIENTS AND METHODS: Fifty-two patients with brain metastases from solid tumors were randomized to oral temozolomide (75 mg/m2/d) concurrent with 40-Gy fractionated conventional external-beam radiotherapy (2 Gy, 5 d/wk) for 4 weeks versus 40-Gy radiotherapy alone. The group receiving temozolomide and radiotherapy continued temozolomide therapy (200 mg/m2/d) for 5 days every 28 days for an additional six cycles. The primary end points were radiologic response and neurologic symptom evaluation. RESULTS: The objective response rate was significantly (P = .017) improved in patients receiving temozolomide and radiotherapy versus radiotherapy alone. Among 24 patients assessable for response in the temozolomide group, 23 (96%) of 24 responded, including nine (38%) patients with a complete response and 14 (58%) patients with a partial response. With radiotherapy alone, 14 (67%) of 21 assessable patients responded, including seven (33%) complete responses and seven (33%) partial responses. There was marked neurologic improvement in the group receiving temozolomide, and the proportion of patients requiring corticosteroids 2 months after treatment was lower in the temozolomide group compared with radiotherapy alone (67% v 91%, respectively). Daily temozolomide concurrent with radiotherapy was generally well tolerated; however, grade ≥ 2 nausea (48% v 13%, P = .13) and vomiting (32% v 0%, P = .004) were significantly increased in the temozolomide group. Hematologic toxicity was predictable and reversible. CONCLUSION: Temozolomide is safe, and a significant improvement in response rate was observed when administered in combination with radiotherapy in patients with previously untreated brain metastases. A larger randomized trial is warranted to verify these results.

A phase II, multicenter, randomized, open-label study to evaluate the safety and tolerability of proxalutamide (GT0918) in subjects with metastatic castrate-resistant prostate cancer (mCRPC).

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 108-108
Author(s):  
Tie Zhou ◽  
Dingwei Ye ◽  
Zhongquan Sun ◽  
Qinggui Meng ◽  
Dalin He ◽  
...  
Keyword(s):  
Dose Level ◽  
Response Rate ◽  
Objective Response ◽  
Specific Antigen ◽  
Stage Iv ◽  
Study Drug ◽  
Progression Free Survival ◽  
Open Label ◽  
Significant Difference ◽  
Psa Progression

108 Background: GT0918 is a 2nd generation of AR antagonist and capability to down-regulate AR level. This study is an open-label, randomized, multicenter, Ph II study to evaluate the safety and efficacy in patients with mCRPC, and to determine the optimal dose for Ph III study. Methods: Patients with historically confirmed mCRPC who progressed after/intolerant to/reluctant to receive Docetaxel and previously treated with abiraterone or enzalutamide were excluded. All the patients received up to 6 cycles or, unacceptable toxicity, or loss of clinical benefit as recommended by PCWG3. Primary endpoint was prostate-specific antigen (PSA) reduction from baseline. Secondary endpoints included time to PSA progression (TTPP), objective response rate (ORR), progression free survival (PFS), disease control rate (DCR) and safety profiles. Results: As of June 30, 2019, 108 treated with GT0918 at three dose levels: 100 mg (n =37), 200 mg (n = 35) and 300 mg (n = 36), the median age of patients was 70.0 years (range 63-77), 88% of patients had stage IV disease at the initial diagnosis and 69.4% had Gleason score ≥ 8. The median duration of disease was 2.88 years. All received prior endocrine therapy, 35.2% received prior chemotherapy, 29.6% received Docetaxel. The median PSA at baseline was 35.285ng/ml, PSA response rate (≥50 % reduction from baseline) was 41.9%. The median time to PSA progression was not reached. There was no significant difference among three arms. Of 19 evaluable patients with target lesions at baseline, the ORR was 15.8% (all were PR) assessed by IRC with RECIST v 1.1, with 20.0% (1/5), 22.2% (2/9), 0 (0/5) at 100, 200, 300 dose level, respectively. The DCR assessed by IRC was 78.9% (CR 0+PR15.8%+SD 63.2%). Of 26 evaluable patients with target lesions at baseline, the ORR was 19.2% assessed by investigators (CR 3.8%+PR 15.4%), with 11.1% (1/9), 20.0% (2/10), 28.6% (2/7) at 100, 200, 300 dose level, respectively. Overall, AEs were experienced by most of patients (94.4 %, n=102). AEs leading to drug interruption were reported in 13 patients (12.0%), 9 (8.3%)of them were suspected to be drug related. AEs leading to discontinuation were reported in 6 patients (5.6%), 3(2.8%) were possibly related to GT0918. 14 patients (13.0%) experienced Grade 3 and 4 AEs. 17 patients (15.7%)experienced SAE, 5(4.6%) of them were suspected to be related to study drug. Most of AEs were mild or moderate. The common suspected AE (≥10%) were asthenia (17.6%, n=19), anemia (14.8%, n=16), AST increased (14.8%, n=16), ALT increased (13.0%, n=14), decreased appetite (13.0%, N=14), white blood cell count decreased (12.0%, n=13), proteinuria (12.0%, n=13). Conclusions: GT0918 showed a manageable safety profile. This study provided preliminary anti-tumor activity in patients with mCRPC. 200mg/day is recommended dose for Ph III trial. Clinical trial information: CTR20170177.

Effects of adding necitumumab to first-line chemotherapy in patients with stage IV non-small-cell lung cancer: Meta-analysis

2019 ◽  
Vol 26 (6) ◽  
pp. 1331-1342
Author(s):  
Irena Ilic ◽  
Sandra Sipetic ◽  
Jovan Grujicic ◽  
Milena Ilic
Keyword(s):  
Overall Survival ◽  
Objective Response Rate ◽  
Advanced Nsclc ◽  
Response Rate ◽  
Meta Analysis ◽  
Objective Response ◽  
Stage Iv ◽  
Progression Free Survival ◽  
First Line ◽  
Free Survival

Introduction Almost half of patients with non-small-cell lung cancer (NSCLC) are diagnosed at an advanced stage. Our aim was to assess the effects of adding necitumumab to chemotherapy in patients with stage IV NSCLC. Material and methods A comprehensive literature search was performed according to pre-specified inclusion and exclusion criteria. Data on overall survival, progression-free survival, objective response rate and adverse events were extracted. A meta-analysis was performed to obtain pooled hazard ratios (HR) and corresponding 95% confidence intervals (CI) for time-to-event data and pooled odds ratio (OR) with 95% CI for dichotomous outcomes. Results The meta-analysis included four randomized clinical trials with 2074 patients. The pooled results showed significant improvement for overall survival (HR = 0.87 (95% CI 0.79–0.95), p = 0.004) when necitumumab was added to chemotherapy in patients with advanced NSCLC. No statistically significant improvement was noted for progression-free survival and objective response rate (HR = 0.83 (95% CI 0.69–1.01), p = 0.06 and OR = 1.46 (95% CI 0.90–2.38), p = 0.13, respectively). Subgroup analysis showed that in patients with non-squamous NSCLC, there was no benefit in overall survival and objective response rate. Patients with advanced NSCLC who received necitumumab were at the highest odds of developing a skin rash (OR = 14.50 (95% CI 3.16–66.43), p = 0.0006) and hypomagnesaemia (OR = 2.77 (95% CI 2.23–3.45), p < 0.00001), while the OR for any grade ≥3 adverse event was 1.55 (95% CI 1.28–1.87, p < 0.00001). Conclusions The addition of necitumumab to standard chemotherapy in a first-line setting in patients with stage IV NSCLC results in a statistically significant improvement in overall survival, while the results were not significant for progression-free survival and objective response rate.

scholarly journals Phase Ib/II Study of Pembrolizumab and Pegylated-Interferon Alfa-2b in Advanced Melanoma

2018 ◽  
Vol 36 (35) ◽  
pp. 3450-3458 ◽  
Author(s):  
Diwakar Davar ◽  
Hong Wang ◽  
Joe-Marc Chauvin ◽  
Ornella Pagliano ◽  
Julien J. Fourcade ◽  
...  
Keyword(s):  
Overall Survival ◽  
Objective Response Rate ◽  
Response Rate ◽  
Objective Response ◽  
Stage Iv ◽  
Progression Free Survival ◽  
Pegylated Interferon ◽  
Gene Signature ◽  
Advanced Melanoma ◽  
Phase Ib

Purpose Objective responses are reported in 34% to 37% of patients with programmed death-1 (PD-1)–naïve advanced melanoma treated with PD-1 inhibitors. Pre-existing CD8+ T-cell infiltrate and interferon (IFN) gene signature correlate with response to PD-1 blockade. Here, we report a phase Ib/II study of pembrolizumab/pegylated (PEG)-IFN combination in PD-1–naïve advanced melanoma. Patients and Methods PEG-IFN (1, 2, and 3 μg/kg per week) was dose escalated using a modified toxicity probability interval design in three cohorts of four patients each, whereas pembrolizumab was dosed at 2 mg/kg every 3 weeks in the phase Ib portion. Thirty-one patients were enrolled in the phase II portion. Primary objectives were safety and incidence of dose-limiting toxicities. Secondary objectives included objective response rate, progression-free survival (PFS), and overall survival. Results Forty-three patients with stage IV melanoma were enrolled in the phase Ib and II portions of the study and included in the analysis. At the data cutoff date (December 31, 2017), median follow-up duration was 25 months (range, 1 to 38 months). All 43 patients experienced at least one adverse event; grade 3/4 treatment-related adverse events occurred in 21 of 43 patients (48.8%). Objective responses were seen at all three dose levels among 43 evaluable patients. The objective response rate was 60.5%, with 46.5% of patients exhibiting ongoing response. Median PFS was 11.0 months in all patients and unreached in responders, whereas median overall survival remained unreached in all patients. The 2-year PFS rate was 46%. Conclusion Pembrolizumab/PEG-IFN demonstrated an acceptable toxicity profile with promising evidence of clinical efficacy in PD-1–naïve metastatic melanoma. These results support the rationale to further investigate this pembrolizumab/PEG-IFN combination in this disease.

scholarly journals Pooled analysis of 115 patients from updated data of Epitopes-HPV01 and Epitopes-HPV02 studies in first-line advanced anal squamous cell carcinoma

2020 ◽  
Vol 12 ◽  
pp. 175883592097535 ◽  
Author(s):  
Stefano Kim ◽  
Aurélia Meurisse ◽  
Laurie Spehner ◽  
Morgane Stouvenot ◽  
Eric François ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Squamous Cell ◽  
Response Rate ◽  
Objective Response ◽  
Locally Advanced ◽  
Complete Response ◽  
Pooled Analysis ◽  
Term Survival ◽  
Anal Squamous Cell Carcinoma

Aims: The addition of docetaxel to cisplatin and 5-fluorouracil (DCF) has shown promising efficacy in advanced squamous cell carcinoma of the anus (SCCA). Preliminary results of Epitopes-HPV01 study showed a high rate of long-lasting complete response to DCF. The prospective, multicenter, Epitopes-HPV02 trial then confirmed the high efficacy of the modified DCF (mDCF) regimen in terms of complete response rate and long-term survival in metastatic or non-resectable locally advanced recurrent SCCA. Here, we present updated results of the Epitopes-HPV01 and Epitopes-HPV02 studies. Patients & methods: Epitopes-HPV01 is a prospective study performed by the regional cancer network of Franche-Comté, France. Epitopes-HPV02 is a phase II study supported by two French collaborative oncological groups, performed in 25 centers. Both studies included patients with metastatic, or with unresectable local recurrent SCCA, treated with DCF regimen. Results: In Epitopes-HPV01, 51 patients were enrolled between September 2012 and January 2019, and 49 patients were included for analysis; while 69 patients were included between September 2014 and December 2016 in Epitopes-HPV02, and 66 patients for analysis. Pooled analysis of 115 patients showed a median progression-free survival of 12.2 months [95% confidence interval (CI) 10.6–16.1] [11.0 months (9.3–16.0) in -HPV02, and 15.6 months (11.2–34.5) in -HPV01, ( p = 0.06)]. The median overall survival was 39.2 months (26.0–109.1) [36.3 in -HPV02 (25.2–NR), and 61.1 months (21.4–120.0) in -HPV01 ( p = 0.62)]. Objective response rate was 87.7% (90.9% in -HPV02 and 83.3% in -HPV01) with 40.3% of complete response (45.5% in -HPV02 and 33.3% in -HPV01). No differences were observed between standard DCF ( n = 54) and mDCF ( n = 58) in terms of OS ( p = 0.57) and PFS ( p = 0.99). 5-years PFS and OS rates were 24.5% and 44.4%, respectively, in the whole population. No treatment-related death was observed. Conclusion: Updated results of Epitopes-HPV01 and 02 studies, as well as the pooled analysis, confirm mDCF as a standard treatment in patients with advanced SCCA.

Phase II Results of Bendamustine in Combination with Rituximab in Relapsed Indolent and Mantle-Cell Non-Hodgkin’s Lymphoma.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 2710-2710 ◽  
Author(s):  
Richard H. Van der Jagt ◽  
Philip Cohen ◽  
Bruce D. Cheson ◽  
Anil Tulpule ◽  
Jordan A. Herst ◽  
...  
Keyword(s):  
Phase Ii ◽  
Objective Response Rate ◽  
Response Rate ◽  
Objective Response ◽  
Complete Response ◽  
Hodgkin's Lymphoma ◽  
Prior Chemotherapy ◽  
Non Hodgkin's Lymphoma ◽  
Mantle Cell ◽  
Grade 3

Abstract Objective: The objective of this study was to evaluate the efficacy and safety of bendamustine HCl (TREANDA®) in combination with rituximab in patients with relapsed non-Hodgkin’s lymphoma (NHL). Background: Bendamustine is a novel hybrid, alkylating agent with single-agent activity in multiple hematologic and solid tumors. It induces cell death via both apoptosis and the apoptosis-independent pathway of mitotic catastrophe. The combination of bendamustine and rituximab has been shown to exhibit a synergistic antitumor effect on NHL cells. Methods: This Phase II, multicenter study enrolled adult patients with relapsed, indolent B-cell or mantle-cell NHL who were not refractory to rituximab (defined as progression ≤6 months of last rituximab dose). Patients received rituximab 375 mg/m2 intravenously (IV) on day 1 and bendamustine 90 mg/m2 IV on days 2 and 3 of a 28-day cycle for 4 to 6 cycles. An additional dose of rituximab 375 mg/m2 IV was given 1 week before the first cycle of bendamustine and 4 weeks after the last cycle. Results: The intent-to-treat (ITT) population included 66 patients (59% men) with a median age of 60 years (range, 40–84). Indolent histologic phenotype was seen in 54 patients with the following histologic subtypes: follicular center cell (61%), small lymphocytic (15%), lymphoplasmacytic (3%), and marginal zone (3%); 18% had mantle-cell lymphoma (MCL). A total of 85% of patients had stage III/IV disease. These patients relapsed from a median of 1 prior chemotherapy (range: 0–5), with 56% having had prior treatment with rituximab. Patients with no prior chemotherapy relapsed following biologic therapy. In the ITT population, the overall objective response rate (ORR) was 94% (complete response [CR]/complete response unconfirmed [CRu], 41%; partial response [PR], 53%); 6% had stable disease. The ORR for the 12 MCL patients was 92% (CR/CRu, 42%; PR 50%). For all patients, the median duration of response and progression-free survival has not been reached after a median follow-up of 8.3 months (range, 0.14–31 months). Grade 3/4 neutropenia was seen in 41% of patients (7%, febrile neutropenia). Common nonhematologic toxicities (grade 1/2, grade 3, grade 4) were nausea (68%, 0%, 0%) and fatigue (53%, 5%, 0%); one patient had grade 3 sepsis. No alopecia was observed. Conclusions: Bendamustine administered in combination with rituximab produced a high objective response rate and was generally well tolerated in patients with relapsed indolent and mantle-cell NHL who were not refractory to rituximab. These results suggest that the combination of bendamustine and rituximab may be comparable in activity to R-CHOP, and further studies of this combination are warranted.

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