scholarly journals Interest in Initiating Corticosteroids By Intravenous Methylprednisolone at Standard Dose in Newly Diagnosed Immune Thrombocytopenia Adults: Results of the Prospective Carmen Registry

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 3736-3736
Author(s):  
Anaïs Essilini ◽  
Thibault Comont ◽  
Johanne Germain ◽  
Natacha Brun ◽  
Claire Dingremont ◽  
...  
Keyword(s):  
Platelet Count ◽  
Treatment Initiation ◽  
Response Rates ◽  
Complete Response ◽  
Rank Test ◽  
Line Treatment ◽  
Full Line ◽  
Log Rank Test ◽  
Kaplan Meier

Abstract Introduction . In France as in many other countries, first-line treatment of adult immune thrombocytopenia (ITP) is based on conventional dose (1 mg/kg/d) oral steroids (CDOS) during 3 weeks. Intravenous polyvalent immunoglobulin (IVIg) is added in case of severe bleeding. However, conventional dose (1 mg/kg/d) intravenous methylprednisolone (CDMP) is often used as a first-line treatment during a few days before continuation with oral prednisone. Indeed, CDMP may induce earlier response in comparison with CDOS due to the absence of intestinal absorption and of hepatic metabolism to be converted in the active substance. No study has assessed the benefits and the safety of this strategy in comparison with CDOS. This was the aim of this study. Methods. This study was conducted within the CARMEN registry. It is the cohort of all newly diagnosed ITP adults (≥ 18 years) recorded in the Midi-Pyrénées region, South of France, from June 2013 (still ongoing). For the present study, we selected all ITP adults included in the CARMEN registry between 05/01/2013 and 12/31/2015 with platelet count <30 x 109/L and treated with corticosteroids. All patients were hospitalized at treatment initiation. We compared two groups: the patients treated by CDOS since ITP diagnosis (CDOS group) and those treated primarily by CDMP followed by CDOS (CDMP group). The primary outcome was the time to response, defined as the time between treatment initiation and response (no bleeding and platelet count >30 x 109/L twice 7 days apart). Secondary outcomes were: the time to complete response, defined as the time between treatment initiation and complete response (no bleeding and platelet count >100 x 109/L twice 7 days apart); the rates of response and of complete response; and the occurrence of adverse drug reactions (ADRs) due to corticosteroids, analyzed by a pharmacologist and an internal medicine physician using the WHO causality scale. The primary outcome and the time to complete response were assessed using Kaplan-Meier curves. The index date was the date of start of treatment. Follow-up was censored in case of occurrence of the outcome, date of start of second-line treatment, death or date of last follow-up, whichever occurred first. All analyzes were adjusted using a propensity score (PS) assessing the probability of being exposed to CDMP vs. CDOS as well as for concurrent IVIg use. The PS included the following variables: age, gender, comorbidity Charlson score, bleeding score, platelet count before treatment and secondary vs. primary ITP. Log-rank tests were used to compare the 2 groups. Hazard ratios (HRs) were calculated using Cox models. Results. The study included 87 patients (24 in the CDMP group and 63 in the CDOS group). Mean age was 67 years (± 22) and 48% were females. ITP was primary in 84% of patients. Mean platelet count was 9.7 x 109/L (± 8.2). Thirty-four patients were also exposed to IVIg. CDMP was prescribed for 3 days in median (range: 1-10). Mean follow-up was 9.4 months (± 8.5). The overall response and complete response rates were 88.5% and 67%, respectively. The median time to response was 3 days in the CDMP group and 4 days in the CDOS group. It was 6.5 and 17 days for complete response, respectively. Response and complete response occurred earlier in the CDMP group (Figure 1A and 1B). However, only a statistical trend was observed for the time to response (adjusted HR: 1.35, 95% confidence interval - CI: 0.76 - 2.41, p<0.3). The adjusted HR for complete response was 2.29 (95% CI: 1.20 - 4.36, p<0.02). Response rates were 87.5% in the CDMP group and 89.0% in the CDOS group (p=1). Complete response rates were 71.0% and 65.0%, respectively (p=0.6). ADRs occurred in 29 (33.3%) patients who experienced 37 corticosteroid-related ADRs. These were mainly infections and diabetes mellitus. There was no difference between the 2 groups. Conclusions. CDMP resulted in an earlier response and complete response than CDOS. Only a trend was observed for the time to response probably due to lack of power to detect smaller variations in platelet counts. In hospitalized patients at ITP onset, initiating CDMP may reduce hospital stay duration. A. Kaplan-Meier curve assessing the probability of response in the CDMP group (full line) and the CDOS group (dotted line); log-rank test: p<0.3. B. Kaplan-Meier curve assessing the probability of complete response in the CDMP group (full line) and the CDOS group (dotted line); log-rank test: p<0.0005. A. Kaplan-Meier curve assessing the probability of response in the CDMP group (full line) and the CDOS group (dotted line); log-rank test: p<0.3. B. Kaplan-Meier curve assessing the probability of complete response in the CDMP group (full line) and the CDOS group (dotted line); log-rank test: p<0.0005. Disclosures Beyne-Rauzy: Celgene, Novartis: Honoraria.

Colorectal Liver Metastases - Does the Number of Lesions Determine the Sensibility of Resection?

Swiss Surgery ◽  
2000 ◽  
Vol 6 (1) ◽  
pp. 6-10
Author(s):  
Knoefel ◽  
Brunken ◽  
Neumann ◽  
Gundlach ◽  
Rogiers ◽  
...  
Keyword(s):  
Liver Metastases ◽  
Colorectal Liver Metastases ◽  
Rank Test ◽  
Log Rank Test ◽  
Kaplan Meier ◽  
Chirurgische Entfernung

Die komplette chirurgische Entfernung von Lebermetastasen bietet Patienten nach kolorektalem Karzinom die einzige kurative Chance. Es gibt jedoch eine, anscheinend unbegrenzte, Anzahl an Parametern, die die Prognose dieser Patienten bestimmen und damit den Sinn dieser Therapie vorhersagen können. Zu den am häufigsten diskutierten und am einfachsten zu bestimmenden Parametern gehört die Anzahl der Metastasen. Ziel dieser Studie war es daher die Wertigkeit dieses Parameters in der Literatur zu reflektieren und unsere eigenen Patientendaten zu evaluieren. Insgesamt konnte von 302 Patienten ein komplettes Follow-up erhoben werden. Die gebildeten Patientengruppen wurden mit Hilfe einer Kaplan Meier Analyse und konsekutivem log rank Test untersucht. Die Literatur wurde bis Dezember 1998 revidiert. Die Anzahl der Metastasen bestätigte sich als ein prognostisches Kriterium. Lagen drei oder mehr Metastasen vor, so war nicht nur die Wahrscheinlichkeit einer R0 Resektion deutlich geringer (17.8% versus 67.2%) sondern auch das Überleben der Patienten nach einer R0 Resektion tendenziell unwahrscheinlicher. Das 5-Jahres Überleben betrug bei > 2 Metastasen 9% bei > 2 Metastasen 36%. Das 10-Jahres Überleben beträgt bislang bei > 2 Metastasen 0% bei > 2 Metastasen 18% (p < 0.07). Die Anzahl der Metastasen spielt in der Prognose der Patienten mit kolorektalen Lebermetastasen eine Rolle. Selbst bei mehr als vier Metastasen ist jedoch gelegentlich eine R0 Resektion möglich. In diesen Fällen kann der Patient auch langfristig von einer Operation profitieren. Das wichtigere Kriterium einer onkologisch sinnvollen Resektabilität ist die Frage ob technisch und funktionell eine R0 Resektion durchführbar ist. Ist das der Fall, so sollte auch einem Patienten mit mehreren Metastasen die einzige kurative Chance einer Resektion nicht vorenthalten bleiben.

Effects of electrical stimulation in the treatment of osteonecrosis of the femoral head

2017 ◽  
Vol 28 (4) ◽  
pp. 434-441
Author(s):  
Salvador Fornell ◽  
Juan Ribera ◽  
Mario Mella ◽  
Andrés Carranza ◽  
David Serrano-Toledano ◽  
...  
Keyword(s):  
Electrical Stimulation ◽  
Retrospective Study ◽  
Femoral Head ◽  
Core Decompression ◽  
Rank Test ◽  
Time To Recurrence ◽  
Log Rank Test ◽  
Kaplan Meier

Introduction: The aim of this study was to examine whether the use of an internal electrostimulator could improve the results obtained with core decompression alone in the treatment of osteonecrosis of the femoral head. Methods: We performed a retrospective study of 41 patients (55 hips) treated for osteonecrosis of the femoral head between 2005 and 2014. Mean follow-up time was 56 (12-108) months. We recorded 3 parameters: time to recurrence of pain, time to conversion to arthroplasty and time to radiographic failure. Survival was estimated using the Kaplan-Meier method. The equality of the survival distributions was determined by the Log rank test. Results: Implanted electrostimulator was a factor that increased the survival of hips in a pre-op Steinberg stage of II or below, while it remained unchanged if the stage was III or higher. Conclusions: The addition of an internal electrostimulator provides increased survival compared to core decompression alone at stages below III.

Prognostic value of immunohistochemical phenotypes (IP) of 141 operable breast cancer patients (pts) included in phase III trials of adjuvant therapy

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 21040-21040
Author(s):  
R. Trujillo ◽  
E. Gallego ◽  
A. Márquez ◽  
N. Ribelles ◽  
J. Trigo ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cox Regression ◽  
Phase Iii ◽  
Rank Test ◽  
Prognostic Effect ◽  
Log Rank Test ◽  
Kaplan Meier ◽  
Phase Iii Trials ◽  
Her 2

21040 Background: Gene expression arrays and IP studies classified breast cancer in three distinct subtypes: basal, HER2/neu and luminal that are associated with different clinical outcomes. Methods: In 141 pts with operable breast cancer, included in phase III trials of adjuvant therapy in our center, immunohistochemical staining was performed on 3μm sections of paraffin blocks, containing tissue-arrays of tumour tissue.A basal phenotype (BP) was defined by negative estrogen receptor (ER) and progesterone receptor (PR) and positive cytokeratin (CK) 5/6 or EGFR immunoreactivity. HER2/neu phenotype as positive c-erb B2 by HercepTest™ and luminal phenotype (LP) by positive ER, PR and CK 7/8 and negative HER-2. Survival curves were calculated by the Kaplan-Meier method. The differences between survivals were estimated using the log rank test. Multivariate Cox regression analysis was used to evaluate any independent prognostic effect of the variables on disease-free survival (DFS). Results: Complete clinical follow-up information was available for 141 pts. The median follow-up period was 52 months (range 1–103 months). During this period, 13.8% pts died from breast cancer and 27.7% pts relapsed. At the time of the primary diagnosis 10.4% of the pts had lymph node negative disease and 89.6% had positive lymph nodes. 50.8% pts received taxane chemotherapy, 7.7% Trastuzumab, 62.3% radiotherapy and 61% pts received hormonotherapy. Positivity for LP was 65.2%, BP 9.9% and Her-2 phenotype 8.5%. 16.3% didn't fit for any of the three subtypes. Median DFS for BP: 24 moths, for LP and Her-2 phenotypes median DFS was not reached. 5 years DFS were; BP: 19%, LP: 63% and Her-2: 56%. Kaplan-Meier survival analyses demonstrated that the presence of a detectable BP was highly significantly associated with a worse DFS compared with the presence of a LP, log rank test (p= 0.0001). Multivariate Cox regression analyses estimated that the prognostic effect of BP in relation to DFS was independent of lymph node, stage and tumor size, HR: 0.12 95% CI (0.05–0.2). Conclusions: We found that expression of BP was associated with poor prognostic in the context of randomized phase III trials. No significant financial relationships to disclose.

Oral (O) versus intravenous (IV) etoposide and platinum in the treatment of extensive-stage small cell lung cancer (SCLC).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 7597-7597 ◽  
Author(s):  
Scott Alan Dorroh ◽  
Eric R Siegel ◽  
Rangaswamy Govindarajan
Keyword(s):  
Poor Performance ◽  
Rank Test ◽  
Test Results ◽  
Extensive Disease ◽  
Tumor Registry ◽  
Log Rank Test ◽  
Kaplan Meier ◽  
Extensive Stage ◽  
Pharmacy Data

7597 Background: Platinum and etoposide chemotherapy is the treatment for patients with SCLC. O etoposide is substituted for IV by many clinicians at twice the dose for bioavailability but the outcome of these subjects has not been studied. To compare the efficacy of O vs. IV etoposide in extensive stage SCLC, a retrospective analysis of subjects treated in the VISN 16 network of 10VA hospitals was undertaken. Methods: Subjects with SCLC diagnosed between 10/1/1996 and 9/30/2010 were identified from the VISN-16 tumor registry. Study was limited to extensive disease by excluding those treated with radiation therapy. Chemotherapy details were obtained from the pharmacy data in the VISN 16 database. Overall survival (OS) was computed as the time in months from the first etoposide issue date to the date of death or last contact. Kaplan-Meier methods were used to compute median OS, and etoposide groups were compared via log-rank test. Results: 300 subjects were eligible for analysis, with median age 67 yrs (range 45-84). 295 deaths were observed during 2,419 total months of follow-up. The median OS of all subjects was 6.3 months (interquartile range (IQR) 2.0-11 months). In addition to platinum, 153 subjects received only O etoposide, 147 received some form of IV etoposide. The median duration (IQR) of therapy for all subjects was 29 (1-110) days; 23 days for those who received any IV etoposide and 43 days for those who received only oral etoposide. The median OS was 7.6 months for those who received only O etoposide vs. 5.4 months for any IV etoposide (P<0.0001). In the latter group, those receiving purely IV etoposide had only 1.5 months’ median OS vs. 8.8 months for those receiving both O and IV etoposide (P<0.0001). Conclusions: Survival of subjects with SCLC treated with O etoposide is comparable to those who received a combination of O and IV therapy. Poor OS for those with only IV therapy may be due to selection bias of poor-performance subjects. [Table: see text]

PET-directed chemoradiation (CRT) with induction FOLFOX compared to induction carboplatin/paclitaxel (CP) in patients with locally advanced esophageal adenocarcinoma (EA).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 4554-4554
Author(s):  
Rebecca Carr ◽  
Meier Hsu ◽  
Kay See Tan ◽  
Manjit S. Bains ◽  
Matthew Bott ◽  
...  
Keyword(s):  
Locally Advanced ◽  
Multivariable Analysis ◽  
Disease Free Survival ◽  
Complete Response ◽  
Rank Test ◽  
Complication Rates ◽  
Trimodality Therapy ◽  
Kaplan Meier ◽  
Multivariable Analyses

4554 Background: Induction chemotherapy with PET-directed CRT and surgery is the standard treatment for locally advanced EA at our institution. Following results of the CALGB 80803 trial, FOLFOX has recently replaced CP as the preferred induction regimen. Methods: We retrospectively evaluated patients with locally advanced EA treated with induction CP vs FOLFOX, followed by trimodality therapy between January 2010 and June 2019. Patients treated with CP with RT followed by surgery without induction chemo were also included. We compared pathological complete response (pCR) and near pCR (ypN0 with ≥90% response) rates in the induction FOLFOX group to the induction CP and no-induction groups. Univariable and multivariable analyses were used to adjust for confounding factors. Disease-free survival (DFS) was estimated by the Kaplan-Meier method and compared between groups using max-combo weighted log rank test. Results: 445 patients were included. Patients in the induction FOLFOX group had significantly higher pCR and near pCR rates vs induction CP patients. Notably, pCR rate was 38% among FOLFOX PET responders vs 19% in non-responders. In multivariable analysis, compared to induction CP, induction FOLFOX administration was an independent predictor of near pCR (OR: 2.22, 95%CI: 1.20-4.20, p = 0.012). Compared to 24% pCR rate among no-induction patients, induction FOLFOX pCR rate was slightly higher at 32%. DFS by 2-years was higher in induction FOLFOX compared to no-induction-treated patients (62% vs. 42%, p = 0.05). Postoperative complication rates were similar among the three groups. Conclusions: PET-directed CRT with FOLFOX instead of CP improves pCR and near pCR rates. Improved DFS was observed in the FOLFOX vs no-induction patients. Longer follow-up is needed to confirm any survival benefits. [Table: see text]

scholarly journals Reoperation rates for symptomatic nonunions in posterior cervical (subaxial) fusions with and without bone morphogenetic protein in a cohort of 1158 patients

2016 ◽  
Vol 24 (4) ◽  
pp. 556-564 ◽  
Author(s):  
Kern H. Guppy ◽  
Jessica Harris ◽  
Jason Chen ◽  
Elizabeth W. Paxton ◽  
Julie Alvarez ◽  
...  
Keyword(s):  
Bone Morphogenetic Protein ◽  
Patient Characteristics ◽  
Rank Test ◽  
Log Rank Test ◽  
Kaplan Meier ◽  
Morphogenetic Protein ◽  
Significant Difference ◽  
Spinal Fusions ◽  
Reoperation Rates

OBJECTIVE Bone morphogenetic protein (BMP) was first approved in 2002 for use in single-level anterior lumbar fusions as an alternative to iliac crest grafts. Subsequent studies have concluded that BMP provides superior fusions rates and therefore reduces reoperations for nonunions. The purpose of this study was to determine the reoperation rates for symptomatic nonunions in posterior cervical (subaxial) spinal fusions with and without the use of BMP and to determine if the nonunion rates are statistically significantly different between the two groups. METHODS Between January 2009 and September 2013, the authors identified 1158 posterior cervical spinal fusion cases in the subaxial spine (C2–7) from a large spine registry (Kaiser Permanente). Patient characteristics, diagnoses, operative times, lengths of stay, and reoperations were extracted from the registry. Reoperations for symptomatic nonunions were adjudicated via chart review. Logistic regression was conducted to produce estimates of odds ratios (OR) and 95% confidence intervals (CIs). Kaplan-Meier curves for the non-BMP and BMP groups were generated and compared using the log-rank test. RESULTS In this cohort there were 1158 patients (19.3% with BMP) with a median follow up of 1.7 years (interquartile range [IQR] 0.7–2.9 years) and median duration to operative nonunion of 0.63 years (IQR 0.44–1.57 years). Kaplan-Meier curves showed no significant difference in reoperation rates for nonunions using the log-rank test (p = 0.179). In a subset of patients with more than 1 year of follow-up, 788 patients were identified (22.5% with BMP) with a median follow-up duration of 2.5 years (IQR 1.7–3.4 years) and a median time to operative nonunion of 0.73 years (IQR 0.44–1.57 years). There was no statistically significant difference in the symptomatic operative nonunion rates for posterior cervical (subaxial) fusions with BMP compared with non-BMP (1.1% vs 0.7%; crude OR 1.73, 95% CI 0.32–9.55, p = 0.527) for more than 1 year of follow-up. CONCLUSIONS This study presents the largest series of patients using BMP in posterior cervical (subaxial) spinal fusions. Reoperation rates for symptomatic nonunions with more than 1 year of follow-up were found to be 1.1% with BMP and 0.7% without BMP. There was no significant difference in the reoperation rates for symptomatic nonunions with or without BMP.

scholarly journals Analisis Ketahanan Hidup Lima Tahun Kanker Tiroid yang Dikelola di RSUP Dr. M. Djamil Padang

2013 ◽  
Vol 2 (3) ◽  
pp. 151
Author(s):  
Oktahermoniza Oktahermoniza ◽  
Wirsma Arif Harahap ◽  
Tofriza Tofriza ◽  
Rosfita Rasyid
Keyword(s):  
Thyroid Cancer ◽  
Tumor Size ◽  
Survival Curve ◽  
Rank Test ◽  
Log Rank Test ◽  
Kaplan Meier ◽  
Histopathological Type ◽  
Meier Survival Curve ◽  
Gender Type

AbstrakKanker tiroid merupakan kanker yang jarang terjadi, namun kanker tersering pada organ endokrin. Tujuan penelitian ini untuk mengetahui ketahanan hidup lima tahun kanker tiroid yang di tatalaksana di RS Dr. M. Djamil Padang dari Januari 2007 sampai dengan Desember 2011. Metode: Subjek penelitian adalah 117 penderita kanker tiroid yang ditatalaksana di RS Dr. M. Djamil Padang dari Januari 2007 sampai dengan Desember 2011. Data dianalisis dengan pendekatan survival time menggunakan Kaplan-Meier survival curve dan Log rank test. Hasil: Median umur 39 tahun (range, 11 sampai 77 tahun), median waktu follow up 32 bulan (range, 1 sampai 70 bulan), median ukuran tumor 6 cm (range, 1 sampai 16 cm). Didapatkan 100 (85,5%) %) penderita sehat bebas tumor, 7 (6%) penderita kambuh lokal, 1 (0,9%) metastasis jauh serta 9 (7,7%) penderita meninggal. Overall five survival rate pada penelitian ini 92,3%. Faktor umur, ukuran tumor, dan jenis histopatologi berhubungan secara bermakna dengan survival (p 0,000), (p= 0,046) dan (p= 0,000). Sedangkan faktor-faktor jenis kelamin, jenis operasi, dan terapi adjuvan tidak mempunyai hubungan bermakna dengan survival. Pembahasan: Umur, ukuran tumor, dan jenis histopatologi memiliki hubungan bermakna dengan survival. Jenis kelamin, jenis operasi, dan terapi adjuvan tidak tidak berhubungan bermakna dengan survival.Kata kunci: Umur, Ukuran Tumor, Jenis Histopatologi, Survival, Kanker TiroidAbstractThyroid cancer is a rare cancer, but most common in endocrine organ. The purpose of this research is to determine about at five year survival of thyroid cancer which recorded at RS M. Djamil Padang Hospital from January 2007 until December 2011. Methods: Subjects were 117 patients with thyroid cancer be recorded in hospital Dr. M. Djamil Padang from January 2007 to December 2011. Data were analyzed with the survival time using Kaplan-Meier survival curve and log rank test. Result: Median age 39 years (range, 11 to 77 years), median follow-up time of 32 months (range, 1 to 70 months), median tumor size was 6 cm (range, 1 to 16 cm). Obtained 100 (85.5%)%) patients with tumor-free healthy, 7 (6%) patients with local recurrence, 1 (0.9%) distant metastases, and 9 (7.7%) patients died. Five overall survival rate in this study was 92.3%. Factors of age, tumor size and histopathological type was significantly associated with survival (p 0.000), (p = 0.046) and (p = 0.000). While the factors gender, type of surgery, and adjuvant therapy had no significant association with survival. Discussion: Discussion: Age, tumor size and histopathological type has a significant relationship with survival. Gender, type of surgery, and adjuvant therapy did not significantly associated with survival.Keywords: Age, Tumor Size, Type of Histopathology, Survival, Thyroid Cancer

scholarly journals Overhydration and low serum prealbumin predict peritoneal dialysis-related peritonitis in continuous ambulatory peritoneal dialysis patients

2020 ◽  
Author(s):  
Quyen Dao Bui Quy ◽  
Tuan Pham Ngoc Huy ◽  
Loc Nguyen Duc ◽  
My Pham Van ◽  
Dung Nguyen Huu ◽  
...  
Keyword(s):  
Peritoneal Dialysis ◽  
Rank Test ◽  
Log Rank Test ◽  
Kaplan Meier ◽  
Low Education ◽  
Curve Model ◽  
Independent Risk Factors ◽  
Low Serum

Abstract Background: In this study, we focused on the role of overhydration (OH) and low serum prealbumin concentration in predicting 3-year peritonitis in continuous ambulatory peritoneal dialysis (CAPD) patients.Methods: We measured serum prealbumin concentration and OH by body composition monitor on 278 CAPD patients (159 males and 119 females) with mean age of 46 years and the median peritoneal dialysis (PD) duration of 21 months. PD-related peritonitis was collected for 3 years. Results: After the 3-year follow-up, 44 patients diagnosed PD-related peritonitis (15.8%). Low education, serum albumin, prealbumin, high CRP-hs and OH were independent risk factors for predicting peritonitis during 36 months in CAPD patients. Based on the ROC curve model and Kaplan–Meier analysis, we realized that patients with low prealbumin and high OH were the independent predictors of 3-year peritonitis in CAPD patients (Prealbumin: AUC = 0.838, cut-off value = 32.5 mg/dL, Se= 90.9%, Sp = 32.9%; OH: AUC = 0.851, cut-off value = 1.33 L, Se = 79.5%, Sp = 85.5%; and Log-rank test p < 0.001, respectively). Conclusion: Overhydration and low serum prealbumin level were the independent predictors of PD-related peritonitis in CAPD patients.

scholarly journals Low-Dose Radiotherapy Versus Moderate-Dose Radiotherapy for the Treatment of Indolent Orbital Adnexal Lymphomas

2021 ◽  
Vol 11 ◽  
Author(s):  
Jonathan Baron ◽  
Christopher M. Wright ◽  
Daniel Y. Lee ◽  
Maribel Carpenter ◽  
Shwetha H. Manjunath ◽  
...  
Keyword(s):  
Low Dose ◽  
Response Rates ◽  
Complete Response ◽  
Moderate Dose ◽  
Exact Test ◽  
Overall Response ◽  
Low Dose Radiotherapy ◽  
Kaplan Meier ◽  
Grade 3

PurposeRadiation therapy (RT) with doses ranging from 24 Gray (Gy) to 40 Gy is a proven treatment modality for indolent orbital adnexal lymphoma (IOAL), but recently the use of low dose RT (LDRT, defined as 2 Gy x 2 fractions) has become a notable alternative. However, limited data exists comparing outcomes following LDRT to moderate-dose RT (MDRT, RT dose 4 – 36 Gy). We present a single institution retrospective analysis comparing outcomes of patients with IOALs following LDRT or MDRT.MethodsA total of 36 patients treated with 38 consecutive courses of RT were identified; LDRT was delivered for 14 courses and MDRT for 24 courses. Overall response rates (ORR) were recorded according to Deauville or RECIST criteria with a response characterized as a complete response (CR) or partial response. Local control (LC), orbital control (OC), and overall survival (OS) rates were estimated with the Kaplan-Meier method. RT toxicity was graded per CTCAEv5 and compared with the Fisher’s exact test.ResultsMedian follow-up time was 29 months (m) (range, 4-129m), and median MDRT dose used was 24 Gy (range 21-36 Gy). Overall response rates (ORR) were 100% (CR 50%) and 87.5% (CR 58.3%) following LDRT and MDRT, respectively. OS at 2 years was 100% and 95% for the LDRT and MDRT groups, respectively (p=0.36). LC rates at 2 years was 100% for both LDRT and MDRT groups and at 4 years was 100% and 89% for the LDRT and MDRT groups, respectively (p=0.56). The 4-year OC rate (including both ipsilateral and contralateral relapses) was 80% and 85% for the LDRT and MDRT groups, respectively (p=0.79). No patient required treatment with RT to a previously irradiated orbit. Acute toxicities were reported following 6 LDRT courses compared to 20 MDRT courses (p=.014). No Grade 3 or higher acute toxicities occurred in either group. Late toxicities were reported following 2 LDRT courses compared to 10 MDRT courses (p=0.147).ConclusionsLDRT produced similar ORR, LC, OC, and OS rates compared to MDRT with fewer acute and minimal late toxicities reported. Future multi-center studies with larger patient numbers are warranted to show significant associations.

Association of improved survival (OS) and tumor control (TC) with interleukin-2 (IL2) with development of immune-related events (IREs): Data from the PROCLAIMSM registry.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 9528-9528
Author(s):  
Brendan D. Curti ◽  
Gregory A. Daniels ◽  
David F. McDermott ◽  
Joseph Clark ◽  
Howard Kaufman ◽  
...  
Keyword(s):  
Interleukin 2 ◽  
Rank Test ◽  
Tumor Control ◽  
Test Results ◽  
Exact Test ◽  
Log Rank Test ◽  
Kaplan Meier ◽  
Long Term Impact

9528 Background: IREs are associated with immunotherapy (IT) for cancer and while reports suggest improvement in TC and OS with induced IREs, the long-term impact is unclear. IL2 has been the major IT for patients (pts) with renal cell carcinoma (RCC) and melanoma (MM) since 1992. We evaluated IREs reports in the PROCLAIMSM data base (2008-2016) of IL2-treated pts. Methods: Reports on 614 (MM) and 843 (RCC) pts were queried for IREs. IREs were categorized as occurring before, during, or after IL-2 and related to any checkpoint inhibitor (CPI). TC (CR+PR+SD) was compared between no IRE and IRE, using Fisher’s exact test. OS curves were estimated by Kaplan-Meier method, and comparison of no IRE/before IL2 with during/after IL2, was analyzed by log-rank test. Results: With a median (med) follow-up of 3.5+ years (range 1-8+ year), 140 IREs were reported in 118 pts (9.6% of all PROCLAIMSM pts): 93 (15%) in MM; 47 (5.6%) in RCC. 25 IREs were prior to IL2; 13 IREs were during IL2; 102 were after IL2. Of the latter 102, 31 were after IL2 and after subsequent CPI; 71 were attributed to IL2 only; and in 13, IREs were due to either IL2 or CPI. TC was 73% for IRE group vs 56% for no IRE group (p = 0.0054). OS was significantly greater for IRE group during/after IL2 compared to no IRE/before IL2 in MM, med 46 months (mo) vs 18 mo (p = 0.0001) and in RCC, med 61 mo vs 43 mo (p = 0.0196), independent of CPI IREs. Med # of IL2 doses was 19 in no IRE group, 39 in IRE during IL2 group, and 25 in IRE after IL2 group. IL2-related IREs were primarily vitiligo and thyroid dysfunction (70% of IL2 IREs), with limited further impact, while CPI-related IREs were often serious, requiring intervention (hypophysitis, colitis, hepatitis, uveitis) (52% of CPI IREs) and possibly chronic management. Conclusions: IREs following IL2 are associated with improved TC and OS. IREs resulting from IL2 and from CPIs are qualitatively different and likely reflect different mechanisms of action of immune activation and response.

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