Simplified gemcitabine and platin regimen for NSCLC to be used in the neoadjuvant setting

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 17155-17155
Author(s):  
G. Cartei ◽  
S. Binato ◽  
C. Sacco ◽  
S. Scalone ◽  
R. Ceravolo ◽  
...  
Keyword(s):  
Liver Function ◽  
Neoadjuvant Therapy ◽  
Hospital Admissions ◽  
Dose Intensity ◽  
Day Hospital ◽  
Normal Kidney ◽  
Intention To Treat ◽  
The Third ◽  
Kidney Liver ◽  
Treat Analysis

17155 Background: Platin (P) salts and Gemcitabine (G) are used for NSCLC. GP regimens frequently included G on day 1, 8 and 15; P on day 2; every 28 days. However, the third G dose often is omitted because of myelo-toxicity, with a consistent no respect of the intended drugs’ doses. We devised a simplified regimen, based on two Day-Hospital admissions per cycle (c), with G on day 1 and 8; P after G on day 8; every 21 days. Aim of study: a high RR within the first 3 c.s for a GP regimen for neoadjuvant therapy. Methods: This prospective, multi-centre investigation included G (1500 mg/m2) on day 1 and 8, and P (100 mg/m2) on day 8 immediately following G, on a 3-weeks-c. Eligible criteria: age 18 to 75 years, NSCLC histologically, no previous chemotherapy, KPS 50%, WBC ≥ 4.0 × 109/L, platelet ≥100 × 109/L and normal kidney-liver function. QoL evaluation: 46 out of 95 valuable patients. Restaging procedures: repeated 3 and 6 c.s. Results: Out of 105 patients, 95 had at least 3 c.s and 59 of them had further 3 c.s. Myelo-toxicity ≥ G3 was mainly neuthropoenia, easily amenable with symptomatic and GCSF therapies; PNS toxicity occurred in 17.9% of patients. QoL was ameliorated (p < 0.05). Therapy was tolerable; gave RR was 52.3% after 3 c.s (Intention-to-treat analysis) and 57.9% in 95 valuable patients after at least 3 therapy c.s. In the 95 valuable patients over the first 42 days, i.e. after 2 c.s and just before the third c., 10 c.s out of 190 were delayed by one week, with a dose intensity reduction of 5.29%. Conclusions: This two Day-Hospital admissions regimen is at least as good as more complex GP regimens, with an appreciable RR after 3c.s; it may be proponed in the neoadjuvant setting. Acknowledgments: Present work was part of studies program of, and partly supported by, AOI (Associazione Oncologia Italiana, Padova, Italy). No significant financial relationships to disclose.

Differences in the exposure to sunitinib in the immediate and deferred cytoreductive nephrectomy (CN) arms of the randomized controlled trial SURTIME.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 703-703
Author(s):  
Yasmin Abu-Ghanem ◽  
Johannes V. Van Thienen ◽  
Christian U. Blank ◽  
Thomas Powles ◽  
Bertrand F. TOMBAL ◽  
...  
Keyword(s):  
Systemic Therapy ◽  
Drug Exposure ◽  
Controlled Trial ◽  
Dose Intensity ◽  
Duration Of Treatment ◽  
Intention To Treat ◽  
Number Of Patients ◽  
Metastatic Sites ◽  
Post Hoc ◽  
Treat Analysis

703 Background: SURTIME compared immediate CN followed by sunitinib 50mg/day (4/2 weeks on-off) 4 weeks after surgery (n=50) versus 3 cycles sunitinib followed by CN in the absence of progression and continued sunitinib 4 weeks after surgery (n=49). In the intention to treat analysis, the hazard ratio of the secondary endpoint overall survival (OS) favored deferred CN [0.57 (CI: 0.34–0.95, p=0.032)] with a median OS of 32.4 (CI: 14.5-65.3) versus only 15.0 months (CI: 9.3–29.5), following immediate CN. We investigated differences in exposure to systemic therapy between the two arms. Methods: Post-hoc exploratory analysis of number of patients receiving sunitinib, overall response rate (ORR) by RECIST 1.1, length of drug exposure and dose intensity in the immediate and deferred arm. Descriptive methods and 95% confidence intervals (CI) were used. Results: In the deferred arm, 97.7% (CI: 89.3-99.6; n=48) received sunitinib versus only 80% (CI: 66.9-88.7, n=40) in the immediate arm. Following immediate CN, 19.6% had confirmed progression at an interval CT scan 4 weeks after CN compared to baseline and 25% started with sunitinib > 4 weeks after surgery. At week 16, 46.0% had progressed at metastatic sites in the immediate CN arm versus 32.7% in the deferred arm, who had a per-protocol recommendation against nephrectomy. In the deferred arm, 83% completed 3 cycles sunitinib with 77.1% at >90%-120% relative dose intensity and an ORR of 29%, reducing the median sum of target lesions from 162 to 127 mm prior to planned CN.Of the patients who started with sunitinib in the immediate (n=40) or continued in the deferred arm after CN (n=29) median duration of treatment was 140 versus 351 days. Conclusions: With immediate CN fewer patients receive systemic therapy, which is administered later and shorter compared to the deferred approach. Starting systemic therapy with sunitinib leads to early and more profound control of the disease and identification of progression prior to planned CN which may translate into the observed survival benefit. Clinical trial information: NCT01099423.

Neoadjuvant therapy for pancreatic cancer: an intention-to-treat analysis

2020 ◽  
Vol 405 (5) ◽  
pp. 623-633
Author(s):  
Kenjiro Okada ◽  
Yoshiaki Murakami ◽  
Kenichiro Uemura ◽  
Naru Kondo ◽  
Naoya Nakagawa ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Neoadjuvant Therapy ◽  
Intention To Treat ◽  
Treat Analysis

Submit Manuscript | http://medc rav eonline.co m Introduction Colorectal adenocarcinoma is the third most common malignant neoplasia and the third leading cause of death from cancer in men and women in the United States. Current data show that the incidence of colorectal adenocarcinoma is decreasing in developed countries but increasing in developing countries. 1 The 2018 estimates of the Bra - zilian National Cancer Institute (Instituto Nacional do Câncer–INCA) were 17,380 new cases in men and 18,980 in women, making col - orectal adenocarcinoma the third most common neoplasia in men and the second most common in women in Brazil. 2 In the past 15 years, rectal cancer management has evolved in several aspects. Specifical - ly, a better understanding of the natural history of the disease, more precise radiological staging, multimodal therapeutic intervention, refined surgical techniques, and more detailed histopathological re - ports may have positively influenced patient survival. In this context, multidisciplinary management of colorectal cancer plays an important role and requires the coordinated teamwork of colorectal surgeons, oncologists, radiologists, and radiotherapists. 3 Total mesorectal exci - sion is still the basis of treatment in rectal cancer. However, neoadju - vant therapy and more conservative practices have been adopted in cases of clinical/pathological responses to radiochemotherapy. 4 Ra - diological evaluation of the response is of paramount importance for the selection of patients eligible for alternative treatment strategies, including ‘watch-and-wait’. Diffusion-weighted imaging is already being used routinely in the evaluation of the pathological response of rectal tumour patients submitted to neoadjuvant therapy. Some re - searchers have tried to estimate the tumour regression grade (TRG) using magnetic resonance imaging, as has been described for post-ra - diochemotherapy pathological evaluation, thus rendering it a valuable instrument. Considering the good results obtained with multimodal therapy in extraperitoneal rectal cancer, the evaluation of the pathological re - sponse post-neoadjuvant therapy must be considered as a factor for safe indication, both for the conservative option, in which the organ is preserved, and for radical surgical resection, influencing the choice between sphincter-preserving surgery and abdominoperineal excision. A precise evaluation, by comparing the results of post-neoadjuvant therapy magnetic resonance imaging with those obtained from his - Int J Radiol Radiat Ther. 2018;5(4):254 ‒ 258. 254 © 2018 Oliveira et al. This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and build upon your work non-commercially. Magnetic resonance imaging is effective in assessing tumour regression after neoadjuvancy in rectal adenocarcinoma

2018 ◽  
Vol 5 (4) ◽  
Author(s):  
Fábio Henrique de Oliveira ◽  
Antônio Lacerda-Filho ◽  
Fábio Lopes de Queiroz ◽  
Tatiana Martins Gomide Leite ◽  
Paulo Guilherme Oliveira Sales ◽  
...  
Keyword(s):  
Magnetic Resonance Imaging ◽  
Rectal Cancer ◽  
Magnetic Resonance ◽  
Neoadjuvant Therapy ◽  
Colorectal Adenocarcinoma ◽  
The United States ◽  
Tumour Regression ◽  
Resonance Imaging ◽  
Cancer Management ◽  
The Third

Manual therapies for pain relief in patients with headache

2015 ◽  
Vol 23 (1) ◽  
pp. 89-96
Author(s):  
Débora Wanderley ◽  
Andrea Lemos ◽  
Larissa de Andrade Carvalho ◽  
Daniella Araújo de Oliveira
Keyword(s):  
Treatment Effect ◽  
Cervicogenic Headache ◽  
Allocation Concealment ◽  
Tension Type Headache ◽  
Manual Therapies ◽  
Osteopathic Manipulation ◽  
Intention To Treat ◽  
Headache Relief ◽  
Type Headache ◽  
Treat Analysis

Objective. This systematic review aimed to assess the efficacy of manual therapies for headache relief. Method. A systematic search in MEDLINE, LILACS, Cochrane, CINAHL, Scopus and Web of Sci­ence databases was conducted for randomized and quasi-randomized trials, with no restrictions for language or year of publication. The de­scriptors were ‘Headache’, ‘Headache disorders’ and ‘Musculoskeletal manipulations’, in addition to the keyword ‘Manual therapy’ and its equivalents in Portuguese. We included studies that compared mas­sage, chiropractic manipulation, osteopathic manipulation and other spinal manipulation to groups with no intervention, other physiother­apeutic modalities or to a sham group. Results. Seven of the 567 ar­ticles initially screened were selected, including patients with tension type headache, cervicogenic headache or migraine. It was not possible to assess the magnitude of the treatment effect on the findings of this review. The main limitations were the absence of randomization and adequate allocation concealment, the lack of blinded evaluators and intention-to-treat analysis and inadequate statistical analysis. Conclu­sions. We were unable to determine the size of the treatment effect due to the selective description of findings. Owing to the high risk of bias in the articles included, the available evidence regarding the ef­ficacy of manual therapies for headache relief is insufficient.

scholarly journals The Treatment Effect of Liver Transplantation versus Liver Resection for HCC: A Review and Future Perspectives

Cancers ◽  
2021 ◽  
Vol 13 (15) ◽  
pp. 3730
Author(s):  
Berend R. Beumer ◽  
Roeland F. de Wilde ◽  
Herold J. Metselaar ◽  
Robert A. de Man ◽  
Wojciech G. Polak ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Liver Transplantation ◽  
Liver Resection ◽  
Early Stage ◽  
Disease Free Survival ◽  
Milan Criteria ◽  
Term Survival ◽  
Equal Distribution ◽  
Intention To Treat ◽  
Treat Analysis

For patients presenting with hepatocellular carcinoma within the Milan criteria, either liver resection or liver transplantation can be performed. However, to what extent either of these treatment options is superior in terms of long-term survival is unknown. Obviously, the comparison of these treatments is complicated by several selection processes. In this article, we comprehensively review the current literature with a focus on factors accounting for selection bias. Thus far, studies that did not perform an intention-to-treat analysis conclude that liver transplantation is superior to liver resection for early-stage hepatocellular carcinoma. In contrast, studies performing an intention-to-treat analysis state that survival is comparable between both modalities. Furthermore, all studies demonstrate that disease-free survival is longer after liver transplantation compared to liver resection. With respect to the latter, implications of recurrences for survival are rarely discussed. Heterogeneous treatment effects and logical inconsistencies indicate that studies with a higher level of evidence are needed to determine if liver transplantation offers a survival benefit over liver resection. However, randomised controlled trials, as the golden standard, are believed to be infeasible. Therefore, we suggest an alternative research design from the causal inference literature. The rationale for a regression discontinuity design that exploits the natural experiment created by the widely adopted Milan criteria will be discussed. In this type of study, the analysis is focused on liver transplantation patients just within the Milan criteria and liver resection patients just outside, hereby ensuring equal distribution of confounders.

Krebstherapie – 68Ga-PSMA-PET/CT beim rezidivierten Prostatakarzinom richtungweisend und kosteneffektiv

2020 ◽  
Vol 25 (04) ◽  
pp. 184-185
Author(s):  
Susanne Krome
Keyword(s):  
Prostate Cancer ◽  
Cancer Recurrence ◽  
Intention To Treat ◽  
Biochemisches Rezidiv ◽  
Choline Pet ◽  
Psma Pet ◽  
Pet Ct ◽  
Prostate Cancer Recurrence ◽  
Treat Analysis

Schwenck J et al. Intention-to-Treat Analysis of 68Ga-PSMA and 11C-Choline PET/CT Versus CT for Prostate Cancer Recurrence After Surgery. J Nucl Med 2019; 60: 1359–1365 15–40 % der Patienten mit einem Prostatakarzinom erleiden postoperativ ein biochemisches Rezidiv. In der retrospektiven Analyse beeinflussten die Bildgebungsverfahren die Häufigkeit einer richtigen Therapiewahl. Die Autoren empfehlen die 68Ga-PSMA-PET/CT, die die höchste Genauigkeit aufwies. Unter Berücksichtigung der Kosten für inadäquate Behandlungen entstünden keine ökonomischen Nachteile.

DAY HOSPITAL ADMISSIONS

1962 ◽  
Vol 2 (23) ◽  
pp. 909-911 ◽  
Author(s):  
J. S. B. Lindsay
Keyword(s):  
Hospital Admissions ◽  
Day Hospital

scholarly journals Impact of narrow margin and R1 resection for hepatocellular carcinoma on the salvage liver transplantation strategy. An intention-to-treat analysis

HPB ◽  
2019 ◽  
Vol 21 (10) ◽  
pp. 1295-1302 ◽  
Author(s):  
Chetana Lim ◽  
Chady Salloum ◽  
Eylon Lahat ◽  
Dobromir Sotirov ◽  
Rony Eshkenazy ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Liver Transplantation ◽  
Intention To Treat ◽  
R1 Resection ◽  
Salvage Liver Transplantation ◽  
Treat Analysis
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