Vinblastine fails to improve response of renal cancer to interferon alfa-n1: high response rate in patients with pulmonary metastases.

1991 ◽  
Vol 9 (5) ◽  
pp. 832-836 ◽  
Author(s):  
J A Neidhart ◽  
S A Anderson ◽  
J E Harris ◽  
J J Rinehart ◽  
J Laszlo ◽  
...  
Keyword(s):  
Response Rate ◽  
Complete Response ◽  
High Response Rate ◽  
Interferon Alfa ◽  
Induction Treatment ◽  
Small Subset ◽  
Research Triangle ◽  
Significant Difference ◽  
To Receive ◽  
Better Than

One hundred sixty-five patients were randomized to receive either interferon alfa-n1 (Wellferon; Burroughs Wellcome Co, Research Triangle Park, NC) alone or with vinblastine. An initial six-cycle induction treatment consisted of interferon given at daily doses of 3, 5, 20, 20, and 20 x 10(6) U/m2 every 2 weeks. Vinblastine at a dose of 10 mg/m2 (later decreased to 5 mg/m2) was given on day 1 of alternate cycles. Toxicities were generally well tolerated. The overall response rate was 10% with no significant difference between treatment arms. Survival was also not significantly different for the arms. A small subset of patients (16) with metastases only to the lungs had a high complete response (CR) and partial response (PR) rate of 44%. Responses were durable, and overall survival of this group was much better than that of the other patients.

scholarly journals Temporal Considerations for Self-Report Research Using Short Message Service

2016 ◽  
Vol 28 (4) ◽  
pp. 200-206 ◽  
Author(s):  
Erin Walsh ◽  
Jay K. Brinker
Keyword(s):  
Repeated Measures ◽  
Short Message Service ◽  
Response Rate ◽  
Time Of Day ◽  
High Response Rate ◽  
Self Report ◽  
Short Message ◽  
Significant Difference ◽  
Message Service ◽  
Working Day

Abstract. When using Short Message Service (SMS) as a tool for data collection in psychological research, participants can be contacted at any time. This study examined how sampling frequency and time of day of contact impacted on response rates, response completeness, and response delay in repeated measures data collected via SMS. Eighty-five undergraduate students completed a six-item self-report questionnaire via SMS, in response to 20 SMS prompts sent on a random schedule. One group responded across 2 days, the other on a compressed schedule of 1 day. Overall, there was a high response rate. There was no significant difference in response rate, completeness, and delay of those responding across 1 or 2 days. Timing between prompts did not impact on response behavior. Responses were more likely to be complete if prompts were sent during the working day. The shortest time between prompts was 15 min, however, and use of an undergraduate sample limits generalizability. When conducting repeated measures sampling using SMS, researchers should be aware that more frequent sampling can be associated with poorer data quality, and should aim to collect data during the working day rather than mornings or evenings.

Obinutuzumab plus lenalidomide (GALEN) in advanced, previously untreated follicular lymphoma in need of systemic therapy

Blood ◽  
2021 ◽  
Author(s):  
Emmanuel Bachy ◽  
Roch Houot ◽  
Pierre Feugier ◽  
Krimo Bouabdallah ◽  
Reda Bouabdallah ◽  
...  
Keyword(s):  
Follicular Lymphoma ◽  
Safety Profile ◽  
Response Rate ◽  
Metabolic Response ◽  
Complete Response ◽  
Tumor Burden ◽  
Common Adverse Event ◽  
Induction Treatment ◽  
High Tumor Burden ◽  
Grade 3

Obinutuzumab and lenalidomide (GALEN) is an active immunomodulatory combination with a manageable safety profile in multiple types of lymphoma. We report efficacy and safety results for the phase 2 GALEN study in previously-untreated patients with advanced follicular lymphoma (FL). Eligible patients aged ≥ 18 years had ECOG PS ≤ 2, high-tumor burden, grade 1-3a FL. Induction treatment was obinutuzumab (1000 mg IV, days 8/15/22, cycle 1; day 1, cycles 2-6) plus lenalidomide (20 mg/day, days 1-21, cycle 1; days 2-22, cycles 2-6) for 6 cycles. Maintenance included obinutuzumab (1000 mg every 2 cycles) plus lenalidomide (10 mg, days 2-22) for ≤ 12 cycles (year 1) followed by obinutuzumab (1000 mg every 56 days) for 6 cycles (year 2). The primary endpoint was complete response rate (CRR) after induction per IWG 1999 criteria. From October 2015 to February 2017, 100 patients were enrolled. CRR after induction was 47% and overall response rate (ORR) 92%. Post-hoc analyses per 2014 Lugano classification including patients with missing bone marrow assessments identified an additional 13 patients fulfilling CRR criteria, resulting in a complete metabolic response of 80% and ORR of 94%. At a median follow-up of 3.7 years, 3-year progression-free and overall survival were 82% and 94%, respectively. The most common adverse event was neutropenia (48% any-grade; 47% grade ≥ 3) but only 2% of patients presented febrile neutropenia; others were mainly grade ≤ 2. No other specific grade ≥3 toxicity occurred at a frequency higher than 3%. Overall, these results demonstrated promising clinical efficacy for the chemo-free backbone obinutuzumab and lenalidomide in previously untreated, high tumor burden FL patients. Except for neutropenia, the safety profile of the combination is remarkable. The study was registered with ClinicalTrials.gov, number NCT01582776

scholarly journals Psychiatrists' appreciation of statistical v. clinical significance: a quick test

2009 ◽  
Vol 33 (8) ◽  
pp. 293-295
Author(s):  
Alan Smith ◽  
James Warner
Keyword(s):  
Critical Appraisal ◽  
Response Rate ◽  
Complete Response Rate ◽  
Statistical Significance ◽  
Complete Response ◽  
Study Data ◽  
Clinical Implications ◽  
Pharmaceutical Advertising ◽  
Transferable Skills ◽  
Better Than

Aims and MethodPharmaceutical advertising material can confuse clinical and statistical significance. We used a brief questionnaire (five questions) to evaluate psychiatrists' appreciation of this difference. This approximated to the level of critical appraisal competence of the MRCPsych part 3 examination.ResultsOf the 113 questionnaires distributed 93 were returned complete (response rate 82%). Senior trainees were significantly better than junior trainees at correctly interpreting data (mean score (maximum 5) 2.61v.2.08; P = 0.04). Consultants did less well than senior trainees, although our sample of consultant respondents was too small for significance testing.Clinical ImplicationsLearning critical appraisal for the MRCPsych examination may provide psychiatrists with valuable transferable skills and prevent gaps in our knowledge being exploited by misleading study data. Psychiatrists of all grades need to maintain their research appraisal skills and should not regard the MRCPsych examination as the end of their learning.

GR 38032F (GR-C507/75): a novel compound effective in the prevention of acute cisplatin-induced emesis.

1989 ◽  
Vol 7 (6) ◽  
pp. 700-705 ◽  
Author(s):  
P J Hesketh ◽  
W K Murphy ◽  
E P Lester ◽  
D R Gandara ◽  
A Khojasteh ◽  
...  
Keyword(s):  
Response Rate ◽  
Complete Response ◽  
High Dose ◽  
Effective Agent ◽  
Acute Emesis ◽  
Major Response ◽  
Hepatic Transaminase ◽  
To Receive ◽  
Administration Schedules ◽  
Antiemetic Agents

We evaluated, in a multi-center trial, the safety and efficacy of GR 38032F (GR-C507/75), a novel and selective serotonin antagonist, in preventing acute emesis in chemotherapy-naive patients receiving treatment with regimens containing high-dose cisplatin (greater than or equal to 100 mg/m2). Eighty-five patients were randomized to receive GR 38032F, 0.18 mg/kg, either every six or every eight hours for three doses, beginning 30 minutes before cisplatin. Patients were evaluated for emetic episodes (vomiting or retching) over a 24-hour period following cisplatin. All patients were evaluable for toxicity and 83 were evaluable for efficacy. The overall antiemetic response rate was 75% (55% complete response [CR], 20% major response). No difference in antiemetic control between the two administration schedules was noted. Patients with histories of heavy ethanol use had significantly better antiemetic control (74% CR) than modest or non-drinkers (33% CR). Toxicity of GR 38032F was modest and independent of administration schedule. The most common adverse events included mild hepatic transaminase elevations, self-limited diarrhea, dry mouth, headache, and mild sedation. Our data indicate that GR 38032F is a safe and effective agent in the control of acute cisplatin-induced nausea and vomiting. Additional trials exploring dosing, schedule, and comparison to standard antiemetic agents are indicated.

Transplantation and Adoptive Cellular Therapy of Cancer: The Role of T-Cell Growth Factors

1993 ◽  
Vol 2 (1) ◽  
pp. 33-47 ◽  
Author(s):  
Michael T. Lotze
Keyword(s):  
Growth Factors ◽  
T Cell ◽  
Cell Growth ◽  
Response Rate ◽  
High Dose ◽  
Specific Lysis ◽  
Modern Development ◽  
Significant Difference ◽  
T Cell Growth ◽  
To Receive

The ability to transfer cultured lymphocytes required the availability and the understanding of the use of the T-cell growth factors IL-2, IL-4, IL-7, and IL-12. Application of these cytokines in vitro and in vivo has allowed the modern development of adoptive transfer of tumor reactive lymphocytes to the modern immunotherapy of patients with cancer. In a randomized prospective study of IL-2 administration compared with IL-2 and lymphokine-activated killer (LAK) cells, no increase in response rate was observed. In a total of 90 patients randomized to receive LAK and IL-2 and 91 patients randomized to receive IL-2 alone, there were a total of 24 responses in patients receiving cells and IL-2 and 16 responses in those receiving IL-2 alone (no significant difference). There was some suggestion that complete responses were observed more often in melanoma patients treated with LAK and IL-2. The most interesting aspect of this study is the prolonged duration of responses, lasting for many months or years. Unfortunately, given the large numbers of variables that were examined, it became very difficult to demonstrate a clear-cut association between clinical outcome (response) and any variable that was routinely measured. Significant antitumor responses have been observed greater than expected with IL-2 alone, with the administration of tumor-infiltrating lymphocytes to patients with melanoma. We currently use hollow fiber devices (Cellco, Germantown, MD) to expand cells up through the many doublings required to generate approximately 1-2 × 1011 cells over a period of 6 wk in culture. In a recent review of the results in patients with melanoma treated on such regimens in combination with high-dose IL-2, an approximately 20-50% response rate has been observed. The factors associated with response are still unclear. Although we initially felt that it was associated with specific lysis, subsequent studies from our group suggest that the relevant factor is specific cytokine (INF-γ, GM-CSF, TNF) production upon tumor stimulation. Additional studies will need to be done to clarify these issues.

Circularly Permuted TRAIL (CPT) combined with Thalidomide for the Treatment of Relapsed or Refractory Multiple Myeloma: An Open-Label, Multicenter Phase II Clinical Trial.

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 2958-2958 ◽  
Author(s):  
Wenming Chen ◽  
Jian Hou ◽  
Yaozhong Zhao ◽  
Lugui Qiu ◽  
Xiaoyan Ke ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Adverse Events ◽  
Phase Ii ◽  
Response Rate ◽  
Complete Response ◽  
Hematologic Malignancies ◽  
Open Label ◽  
Refractory Multiple Myeloma ◽  
Phase Ii Studies ◽  
Better Than

Abstract Abstract 2958 Background: Circularly permuted TRAIL (CPT) is a recombinant mutant of human Apo2L/TRAIL developed by Beijing Sunbio Biotech Co. Ltd. as a targeted therapy for multiple myeloma and other hematologic malignancies. CPT is a dual pro-apoptotic receptor agonist that directly activates both pro-apoptotic receptors TRAIL-R1 (DR4) and TRAIL-R2 (DR5). CPT selectively induces apoptosis in a variety of cancer cells, while sparing most normal cells in preclinical models. Objective: CPT as a mono-therapy has shown definitive activities for patients with relapsed or refractory multiple myeloma (Rel/Ref MM) in phase I and phase II studies. The aim of this study is to observe the effect and safety of CPT in combination with thalidomide for Rel/Ref MM patients. Methods: In this multiple-center, open-label, single arm phase II study, 43 Rel/Ref MM patients who had received prior therapies and were resistant to thalidomide were recruited. These patients were divided into three groups, and received CPT 5.0mg/kg, 8.0mg/kg, and 10.0mg/kg on days1–5 of each 21-day cycle, respectively, until having finished six cycle‘s treatment or progression disease or intolerant adverse events. All the patients received thalidomide 100mg daily until to the disease progression or intolerant adverse events. Clinical responses of CPT were assessed by an independent review committee according to the criteria of the European Group for Blood and Marrow Transplantation (EBMT). Results: Among the 43 patients, 41 patients can be evaluated. There were 11, 15 and 15 patients in the three groups respectively. Among the 41 patients, two patients achieved complete response (CR), three showed near complete responses (nCR), four exhibited partial responses (PR), and five obtained minor responses (MR). The total response rates were 34% (including MR or better than MR), or 22% (including PR or better than PR). Among the three groups, the dose of 10mg/kg seemed to be optimal with 26.7% response rate (including PR or better than PR), superior to the other two groups. Duration of response of CPT was not evaluated accurately, because most patients who achieved PR, nCR, or CR were progression free at the end of the trial. The common treatment related adverse events (≥10%) were neutropenia, leucopoenia, fever, AST/ALT/LDH elevation, and thrombocytopenia. The grade 3 non-haematological toxicities were AST elevation (4.65%) and LDH elevation (2.33%). The elevation of AST and LDH seems to be related to tumor lysis, but not to liver injury. The grade 4 haematological toxicities were neutropenia and thrombocytopenia (2.33%, respectively) which might be related to thalidomide. Conclusions: The CPT combined with thalidomide was well-tolerated and an effective regimen for the treatment of Rel/Ref MM. The combination of CPT and thalidomide seems to be superior to CPT alone in CR/nCR response rate. Disclosures: Zheng: Beijing Sunbio Biotech Co., Ltd.: Employment. Zhu:Beijing Sunbio Biotech Co., Ltd.: Employment. Yang:Beijing Sunbio Biotech Co., Ltd.: Employment.

Role of a modified epigastric port in reducing post operative pain and causing early ambulation in a patient undergoing laparoscopic cholecystectomy as compared to a standard four port procedure, a randomized controlled study

2020 ◽  
Vol 7 (12) ◽  
pp. 3986
Author(s):  
Arijit Roy ◽  
Pramatha Nath Datta ◽  
Kushankur Guha
Keyword(s):  
Laparoscopic Cholecystectomy ◽  
Postoperative Recovery ◽  
Controlled Study ◽  
Post Operative Pain ◽  
Quality Life ◽  
Significant Difference ◽  
Group A ◽  
Group B ◽  
To Receive ◽  
Better Than

Background: Standard four port laparoscopic cholecystectomy is the gold standard in the treatment of gall stones. Modified epigastric port laparoscopic cholecystectomy may be considered an alternative, as this procedure maintains the advantages of four ports and does not require any special set of instruments. In this study we aimed to see whether this procedure is comparable to the standard four port laparoscopic cholecystectomy based on the primary objectives of postoperative pain score, degree of ambulation, time to return to normal activities.Methods: Consecutive patients due to undergo laparoscopic cholecystectomy, meeting all the predefined criteria were recruited into the study. The group A was assigned to receive intervention in the form of modified epigastric port laparoscopic cholecystectomy. The group B was assigned to receive intervention in the form of standard four port laparoscopic cholecystectomy. Patients in group A were compared with patients in group B based on multiple pre-defined parameters.Results: Pain scores were significantly better in group A. Degree of ambulation at was significantly better in group A. In respect to the time to resumption of normal activities there was no significant difference between the two groups. When comparing the quality life at 1 month following surgery with SF-36 health survey, the patients in group A did better than patients in group B with respect to the six scales. Conclusions: Modified epigastric port laparoscopic cholecystectomy appears to be significantly better than the standard four port cholecystectomy in terms of postoperative recovery.

cT3N0 rectal cancer: Potential overtreatment with preoperative chemoradiation (CRT) is warranted

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 3568-3568
Author(s):  
J. G. Guillem ◽  
J. Diaz-Gonzalez ◽  
B. Minsky ◽  
M. Rodriguez-Bigas ◽  
S. Jeong ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Anal Verge ◽  
Pathologic Complete Response ◽  
Radical Resection ◽  
Complete Response ◽  
Median Number ◽  
Mri Staging ◽  
Significant Difference ◽  
The Us ◽  
To Receive

3568 Background: Although CRT has emerged as the preferred treatment for T3 and/or lymph node (LN) positive rectal cancer, Sauer et al (NEJM 2004) demonstrated that 18% of patients deemed suitable for preop CRT via endorectal ultrasound (ERUS) were overstaged and therefore received unnecessary preoperative CRT. Since data also suggest that LN negative rectal cancer s/p TME may not need adjuvant therapy, it is reasonable to consider the omission of radiotherapy for the cT3N0 subset. We therefore determined the accuracy of pre-CRT ERUS/MRI staging in order to explore the validity of a non-radiation approach for cT3N0 disease. Methods: 188 ERUS/MRI staged T3N0 rectal cancer patients from 6 insitutions in the US, Europe and Asia received preoperative CRT (5-FU based and 45–52.5 Gy) followed by radical resection. Rates of pathologic complete response (pCR) and mesorectal LN involvement were determined. Results: Tumors were located a median of 5 centimeters from the anal verge. Sphincter-preserving surgery was performed in 135 (81%) patients. Overall pCR was 19%. Median number of LN sampled was 9 (range 0–38). Rate of positive LN was significantly associated with T-stage: pT0: 3%, pT1: 7%, pT2: 20%, pT3–4: 36%(p=0.001). 41 patients (22%) had pathologically positive mesorectal LN. There was no significant difference in rate of positive LN between those staged by ERUS and MRI(25% vs 16%, p=0.19). Conclusions: Accuracy of preoperative ERUS/MRI for identifying mid to distal T3N0 rectal cancer is limited, as 22% will have undetected mesorectal LN involvement despite CRT. Therefore, ERUS/MRI staged T3N0 patients should continue to receive preoperative CRT. Although 19% are overstaged and therefore overtreated, our data suggest that an even larger number would be understaged and require postoperative CRT, which is associated with inferior local control, higher toxicity, and poor functional outcome. No significant financial relationships to disclose.

Bortezomib-Melphalan-Prednisone-Thalidomide Followed by Maintenance With Bortezomib-Thalidomide Compared With Bortezomib-Melphalan-Prednisone for Initial Treatment of Multiple Myeloma: Updated Follow-Up and Improved Survival

2014 ◽  
Vol 32 (7) ◽  
pp. 634-640 ◽  
Author(s):  
Antonio Palumbo ◽  
Sara Bringhen ◽  
Alessandra Larocca ◽  
Davide Rossi ◽  
Francesco Di Raimondo ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Overall Survival ◽  
Response Rate ◽  
Complete Response Rate ◽  
Progression Free Survival ◽  
Complete Response ◽  
Free Survival ◽  
Grade 3 ◽  
To Receive

Purpose Bortezomib-melphalan-prednisone (VMP) has improved overall survival in multiple myeloma. This randomized trial compared VMP plus thalidomide (VMPT) induction followed by bortezomib-thalidomide maintenance (VMPT-VT) with VMP in patients with newly diagnosed multiple myeloma. Patients and Methods We randomly assigned 511 patients who were not eligible for transplantation to receive VMPT-VT (nine 5-week cycles of VMPT followed by 2 years of VT maintenance) or VMP (nine 5-week cycles without maintenance). Results In the initial analysis with a median follow-up of 23 months, VMPT-VT improved complete response rate from 24% to 38% and 3-year progression-free-survival (PFS) from 41% to 56% compared with VMP. In this analysis, median follow-up was 54 months. The median PFS was significantly longer with VMPT-VT (35.3 months) than with VMP (24.8 months; hazard ratio [HR], 0.58; P < .001). The time to next therapy was 46.6 months in the VMPT-VT group and 27.8 months in the VMP group (HR, 0.52; P < .001). The 5-year overall survival (OS) was greater with VMPT-VT (61%) than with VMP (51%; HR, 0.70; P = .01). Survival from relapse was identical in both groups (HR, 0.92; P = .63). In the VMPT-VT group, the most frequent grade 3 to 4 adverse events included neutropenia (38%), thrombocytopenia (22%), peripheral neuropathy (11%), and cardiologic events (11%). All of these, except for thrombocytopenia, were significantly more frequent in the VMPT-VT patients. Conclusion Bortezomib and thalidomide significantly improved OS in multiple myeloma patients not eligible for transplantation.

scholarly journals Natural interferon-alpha in combination with melphalan/prednisone versus melphalan/prednisone in the treatment of multiple myeloma stages II and III: a randomized study from the Myeloma Group of Central Sweden

Blood ◽  
1993 ◽  
Vol 81 (6) ◽  
pp. 1428-1434 ◽  
Author(s):  
A Osterborg ◽  
M Bjorkholm ◽  
M Bjoreman ◽  
G Brenning ◽  
K Carlson ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Overall Survival ◽  
Randomized Study ◽  
Remission Induction ◽  
Induction Treatment ◽  
Hematologic Toxicity ◽  
Response Frequency ◽  
Treatment Groups ◽  
Significant Difference ◽  
To Receive

Three hundred thirty-five previously untreated patients with multiple myeloma in clinical stages II and III entered a randomized trial comparing intermittent oral melphalan and prednisone (MP) therapy (n = 171) with MP in combination with natural (leukocyte-derived) alpha- interferon (MP/IFN) (n = 164). The treatment groups were comparable with regard to major prognostic factors. The response frequency was 42% in the MP group and 68% in the MP/IFN group (P < .0001). Eighty-five percent of IgA myelomas and 71% of Bence-Jones myelomas responded to MP/IFN compared with 48% and 27%, respectively, to MP treatment (P = .001). There was no difference in the overall survival between the two treatment groups. However, the survival of 72 patients with IgA or Bence-Jones myeloma randomized to receive MP/IFN was significantly longer (median 32 months) than that of 71 patients treated with MP (median 17 months) (p < .05). No statistically significant difference in response frequency (60% v 46%) or survival was found for patients with IgG myeloma. Hematologic toxicity, WHO grades III and IV, was higher in the MP/IFN group (48%) than in the MP group (33%) (P <.05) during the induction treatment period. Flulike syndrome was observed in 68% of patients receiving MP/IFN. The results show that MP/IFN is a well-tolerated treatment regimen, superior to MP for remission induction, and it improves significantly the overall survival for patients with IgA and Bence-Jones myelomas.

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