Phase II trial of preoperative cisplatin-irinotecan followed by concurrent cisplatin-irinotecan and radiotherapy: PET scan after induction therapy may identify early treatment failure

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 4023-4023 ◽  
Author(s):  
D. H. Ilson ◽  
M. Bains ◽  
N. Rizk ◽  
M. Shah ◽  
V. Rusch ◽  
...  
Keyword(s):  
Phase Ii ◽  
Early Treatment ◽  
Phase Ii Trial ◽  
Prognostic Significance ◽  
Feeding Tube ◽  
Pet Scan ◽  
R0 Resection ◽  
The Mean ◽  
C 30

4023 Background: Response on PET scan during preoperative chemotherapy (chemo) for esophageal cancer (EC) has prognostic significance [JCO 19:3058;2001]. Induction chemo with weekly irinotecan(I)/cisplatin(C) relieves dysphagia, and weekly I/C administered with radiotherapy (RT) is well tolerated [ProcASCO 23:Abs 4017;2005]. We completed a Phase II trial of induction I/C followed by I/C/RT followed by surgery. Repeat PET scan was performed after induction chemo and prior to RT. Methods: Patients (pts) with resectable EC/GE junction carcinoma were staged with EUS, PET, and CT scan. Induction chemo consisted of I-65 mg/m2 and C-30 mg/m2 weeks 1,2,4,5, and weeks 7,8,10,11 with RT (180 cGy daily fractions to 5040 cGy). PET scan was repeated at week 6. Esophagectomy was planned 4–8 weeks after RT. Results: 60 pts were enrolled: 6 inevaluable, 54 evaluable, 3 await surgery; 49 male (91%), 5 female (9%), 41 adenocarcinoma (76%), 13 squamous (24%), median age 59, median PS 0, EUS T3N1 35 (65%), N1 40 (74%). Of 41 pts with dysphagia, 31 (76%) had resolution/improvement with induction chemo and 3/54 (6%) required a feeding tube. Of 51 pts, 3 clinical complete responders (CR) deferred surgery (1 refusal, 2 medically inoperable). Of 48 pts, 4 progressed during induction (8%), 9 progressed during RT (19%), and 35 underwent R0 resection (73%). 9/48 (19%) achieved pathologic CR. The median overall survival was 35.4 mos (median follow up 15 mos). In exploratory analysis in 54 pts, response after induction on the week 6 PET scan measured as a decline in SUV, correlated with time to tumor progression (TTP). The mean change in SUV was 43%. A set point of 22% or greater decline in SUV (PET responder) yielded the greatest distinction in TTP (PET responders TTP 18.5 mos, vs nonresponders 5.5 mos, p = 0.03). 4 pts with progression during induction crossed over to RT with paclitaxel: 3 (2 squamous, 1 adenocarcinoma) achieved durable disease control (one pathologic CR, one pathologic PR, one clinical CR). Conclusions: Response on PET scan during induction chemo for EC may identify early treatment failures, and may direct pts to successful salvage with alternative chemo during RT. Supported by a grant from Pfizer. [Table: see text]

Triple induction chemotherapy and chemoradiotherapy in locally advanced esophageal cancer: Final results of a multicenter phase II trial

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 4568-4568
Author(s):  
W. M. Eisterer ◽  
A. De Vries ◽  
B. Spechtenhauser ◽  
D. Kendler ◽  
A. Königsrainer ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Trial ◽  
Performance Status ◽  
Locally Advanced ◽  
Neoadjuvant Chemoradiotherapy ◽  
R0 Resection ◽  
Ecog Performance Status ◽  
Blurred Vision ◽  
Hyperfractionated Radiotherapy

4568 Background: Surgery is the standard treatment for patients with resectable esophageal carcinoma, but 5-year survival rates rarely exceed 20%. Neoadjuvant chemoradiotherapy (CRT) may lead to downstaging of the tumor and thus improve the possibility of complete oncologic resection. Docetaxel (Dx) showed considerable activity in combination with hyperfractionated radiotherapy and only moderate toxicity. We evaluated a triple neoadjuvant regime including Dx in patients with locally advanced esophageal adenocarcinoma (AC) or squamos cell carcinoma (SCC). Methods: 24 patients (pts) with AC (n=8) or SCC (n=16) medically fit, no prior therapy, ECOG-performance status = 2 were included. Pts received 2 cycles of cisplatin (Cis) 15mg/ms2 d1–5, 5-fluorouracil (5-FU) 750mg/m2 continuous infusion (CI) d1–5, and Dx 75mg/m2 d1 repeated every 29 days followed by radiotherapy (RT) 39.6 Gy total dose (daily fraction 1.8Gy) concomitant to Dx 15mg/m2 on days 1, 8, 15, 22 and 5-FU 300mg/m2 CI on the days of RT followed by resection or definitive RT up to 59.6 Gy in case of inoperability. Results: See table . Grade 3/4 toxicity (n/%): neutropenia 10/43%, diarrhea 4/18%, alopecia 2/9%; deep vein thrombosis 1/5%, blurred vision 1/5%, fever 1/5%, pulmonary embolus 1/5%, arterial hypertension 1/5%. 1 pt died 39 days post resection due to fatal anastomical bleeding. 6/16 operated pts (37%) showed morbidity (anastomical stenosis/insufficiency, fistula, nervus recurrens palsy). 4/22 pts (18%) died 7- 25 months after therapy due to metastatic disease. At a median follow-up of 12 months 18 pts (82%) are alive, median survival has not been reached yet. Conclusions: Triple induction CT and CRT with Dx, Cis, and 5-FU is safe, feasible, and effective with CPR in 31%, downstaging in 81% and R0-resection in 100% of pts. Main toxicities are neutropenia (43%) and postoperative morbidity (37%). A follow-up phase II trial of triple induction therapy in combination with an EGFR-directed antibody is planned. [Table: see text] No significant financial relationships to disclose.

Phase II trial of bevacizumab, irinotecan, cisplatin, and radiation as preoperative therapy in esophageal adenocarcinoma.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 4061-4061
Author(s):  
David Ilson ◽  
Karyn A. Goodman ◽  
Yelena Yuriy Janjigian ◽  
Manish A. Shah ◽  
David Paul Kelsen ◽  
...  
Keyword(s):  
Pulmonary Embolism ◽  
Esophageal Adenocarcinoma ◽  
Phase Ii ◽  
Surgical Complications ◽  
Phase Ii Trial ◽  
Endoscopic Biopsy ◽  
Phase Iii ◽  
R0 Resection ◽  
Esophagogastric Cancer ◽  
C 30

4061 Background: Preop chemo and radiotherapy (RT) with weekly irinotecan (I), cisplatin (C) and 5040 cGy is tolerable and active [Cancer, in press]. Bevacizumab (B) + weekly I/C in advanced esophagogastric cancer increased response rate and PFS without an increase in toxicity [JCO 24: 5201; 2006]. In a phase II trial in esophageal adenocarcinoma (EA) we combed B + I/C with RT as preop therapy. A toxicity analysis after 10 patients (pts) undergoing surgery indicated no unexpected toxicity with B [JCO 27: Abstract 4573; 2009], and we completed a planned accrual of 33 pts. Methods: Pts had resectable distal esophageal or Siewert’s I or II EA, T2-3 or N1 staged by EUS, PET, and CT scan. Induction chemo: I: 50-65 mg/m2 + C: 30 mg/m2 weeks 1,2,4,5, B: 7.5 mg/kg weeks 1 and 4; Chemort: 180 cGy daily fractions to 5040 cGy, I/C weeks 7,8,10,11+ B weeks 7,10. Esophagectomy was planned 6-8 weeks after RT. Postop: B: 7.5 mg/kg every 3 weeks for 8 cycles. Results: 33 pts were enrolled. 26 male: 7 female; distal esophagus 11 (33%), GEJ 22 (67%); 21 T3N1 (64%); 10 T3N0 (30%); 2 T2N0-1 (6%). 25/33 pts went to surgery (76%), 24 had R0 resection (73%). Pathologic CR 5 pts (15%). 8 pts did not going to surgery: 2 for adverse events (9%, 1 CVA due to patent foramen ovale, 1 esophageal perforation due to endoscopic biopsy), 6 for progressive disease (18%). 21/24 pts (88%) received adjuvant B, 20 (95%) completed all cycles. Grade 3/4 toxicity in 30 evaluable pts during chemort: 24% neutropenia, 3% neutropenic fever, 23% esophagitis, 13% dehydration, 13% thrombocytopenia, 7% pulmonary embolism, 3% nausea/vomiting. Surgical complications: 3 anastomotic leaks (12%), 4 respiratory failure (16%), 1 pulmonary embolism (4%), 2 post op deaths (8%). At a median follow up of 20 months, PFS was 14 months and OS was 30 months. Conclusions: The addition of B to preop chemoRT in EA was tolerable without increase in treatment toxicity or surgical complications. There was no suggestion of improved pathologic CR, PFS, or OS with the addition of B to I/C/RT. Evaluation of B in phase III trials of chemort does not appear warranted. Supported by a grant from Genentech.

Phase II trial of bevacizumab, irinotecan, cisplatin, and radiation as preoperative therapy in esophageal adenocarcinoma.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 67-67 ◽  
Author(s):  
David Ilson ◽  
Karyn A. Goodman ◽  
Yelena Yuriy Janjigian ◽  
Manish A. Shah ◽  
David Paul Kelsen ◽  
...  
Keyword(s):  
Pulmonary Embolism ◽  
Esophageal Adenocarcinoma ◽  
Phase Ii ◽  
Surgical Complications ◽  
Phase Ii Trial ◽  
Endoscopic Biopsy ◽  
Phase Iii ◽  
R0 Resection ◽  
Esophagogastric Cancer ◽  
C 30

67 Background: Preop chemo and radiotherapy (RT) with weekly irinotecan (I), cisplatin (C) and 5040 cGy is tolerable and active [Cancer, in press]. Bevacizumab (B) + weekly I/C in advanced esophagogastric cancer increased response rate and PFS without an increase in toxicity [JCO 24: 5201; 2006]. In a phase II trial in esophageal adenocarcinoma (EA) we combined B + I/C + RT as preop therapy. A toxicity analysis after 10 patients (pts) undergoing surgery indicated no unexpected toxicity with B [JCO 27: Abstract 4573; 2009]. We completed a planned accrual of 33 pts. Methods: Pts had resectable Siewert’s I or II EA, T2-3 or N1 staged by EUS, PET, and CT scan. Induction chemo: I 50-65 mg/m2 + C 30 mg/m2 weeks 1,2,4,5, B 7.5 mg/kg weeks 1 and 4; Chemort: 180 cGy daily fractions to 5040 cGy, I/C weeks 7,8,10,11+ B weeks 7,10. Esophagectomy was planned 6-8 weeks after RT. Postop: B 7.5 mg/kg every 3 weeks for 8 cycles. Results: 33 pts were enrolled. 26 male: 7 female; 13 Siewert I (39%): 20 Siewert II (61%); 21 T3N1 (64%); 10 T3N0 (30%); 2 T2N0-1 (6%). 25/33 pts went to surgery (76%), 24 had R0 resection (73%). Pathologic CR 4/33 pts (12%). 8 pts did not go to surgery: 2 for adverse events (9%, 1 CVA due to patent foramen ovale, 1 esophageal perforation due to endoscopic biopsy), 5 for progressive disease (15%). 21/24 pts (88%) received adjuvant B, 20 (95%) completed all cycles. Grade 3/4 toxicity in 30 evaluable pts during chemort: 27% neutropenia, 3% neutropenic fever, 23% esophagitis, 13% dehydration, 13% thrombocytopenia, 7% pulmonary embolism, 3% nausea/vomiting. Surgical complications: 3 anastamotic leaks (12%), 4 respiratory failure (16%), 1 pulmonary embolism (4%), 2 post op deaths (8%). At a median follow up of 20 months, PFS was 14 months and OS was 30 months. Conclusions: The addition of B to preop chemoRT in EA was tolerable without increase in treatment toxicity or surgical complications. There was no suggestion of improved pathologic CR, PFS, or OS with the addition of B to I/C/RT. Evaluation of B in phase III trials of chemort does not appear warranted. Supported by a grant from Genentech.

Outcomes of a Cardiac Rehabilitation (CRH) Program after phase II: what about our patients almost 4 years later?

2021 ◽  
Vol 28 (Supplement_1) ◽  
Author(s):  
J Borrego Rodriguez ◽  
C Palacios Echevarren ◽  
S Prieto Gonzalez ◽  
JC Echarte Morales ◽  
R Bergel Garcia ◽  
...  
Keyword(s):  
Phase Ii ◽  
Hospital Readmissions ◽  
Clinical Results ◽  
Level Of Evidence ◽  
Coronary Syndrome ◽  
Funding Sources ◽  
The Mean ◽  
Acute Cardiovascular Event ◽  
Mean Time

Abstract Funding Acknowledgements Type of funding sources: None. INTRODUCTION CRH in patients with ischemic heart disease is recommended by the different clinical practice guidelines with an IA level of evidence, with an important role in reducing cardiovascular mortality and hospital readmissions during follow-up. OBJECTIVE The goal of this study is to show the 4-year clinical results of a population of patients who participated in an CRH program after an Acute Coronary Syndrome (ACS). METHODS Between May/2014 and September/2017, 221 patients who had recently presented an ACS completed the 12 weeks of phase II of the CRH program at our center. In May/2020 we collected epidemiological, clinical and echocardiographic information at the time of the acute cardiovascular event; and we evaluate the current vital status of the patients and the incidence of readmissions for: angina, HF, new ACS, or arrhythmic events. RESULTS Of the 221 patients, 182 were men (82%). The mean age of our population was 58.3 ± 7.8 years. 58% (129 patients) suffered from ST-elevation ACS. The mean time of hospital stay was 6.20 ± 2.9 days. An echocardiogram was performed at discharge, which showed an average LVEF of 56 ± 6%. Eight patients (4%) developed early Ventricular Fibrilation (VF) during the acute phase of ACS. Among the classic CVRF, smoking (79%) was the most prevalent, followed by dyslipidemia (53%) and hypertension (47%). The mean time from hospital discharge to the start of phase II RHC was 42 ± 16 days. The overall incidence of events was 9%: 10 patients suffered reinfarction during follow-up, and 7 were readmitted for unstable angina, all of whom underwent PCI; no patient was admitted for HF; and none of the 8 patients with early VF had a new tachyarrhythmia, registering a single admission for VT during follow-up. None of the patients had sustained ventricular tachyarrhythmias during exercise-training. At the mean 4.5-year follow-up, 218 patients were still alive (98%). CONCLUSION The incidence of CV events in the follow-up of our cohort was low, which can be explained by the fact that it is a young population, with an LVEF at low limits of normality at discharge, which is one of the most important predictors in the prognosis after an ischemic event. As an improvement, we must shorten the time until the start of phase II of the program. CRH shows once again its clinical benefit after an ACS, in consonance with the existing evidence. Abstract Figure. Outcomes of a CRH program.

scholarly journals Lack of Prognostic Significance of Pre-Treatment Total Metabolic Tumor Volume (TMTV) in Diffuse Large B-Cell Lymphoma (DLBCL)

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 1720-1720
Author(s):  
Mayur Narkhede ◽  
Sadaf Qureshi ◽  
Maryam Yazdy ◽  
Roxanna Juarez ◽  
Giuseppe Esposito
Keyword(s):  
Ct Scan ◽  
B Cell ◽  
Prognostic Significance ◽  
B Cell Lymphoma ◽  
Pet Ct ◽  
The Mean ◽  
Pre Treatment ◽  
Pet Ct Scan ◽  
Stage Stage

Abstract Background DLBCL is the most common non-Hodgkin lymphoma (NHL), making up about 30%-40% of NHL in the U.S. PET-CT is recommended as the most accurate imaging technique in DLBCL for staging and response assessment. Pretreatment assessment of PET-CT scan derived metrics such as TMTV has been shown to correlate with PFS and/or overall survival (OS) in DLBCL (Sasanelli 2014) We attempted to replicate this finding using EFS at 24 months as a primary endpoint and compare it with pre-treatment TMTV, TLG and cell of origin (COO). Methods 47 pts with newly diagnosed DLBCL and treated with R-CHOP at our institution between 2014 to 2018 were identified from our electronic medical record system for retrospective analysis after IRB approval. All pts had a pretreatment PET-CT scan available for TMTV measurement. All pts had a pretreatment biopsy which were reviewed along with their clinical information regarding treatment outcome and follow up. Patients were classified as to germinal center B cell (GCB) and non-GCB based on immunochemistry using the Hahn's algorithm. PET-CT scans were reviewed by two nuclear medicine physicians using synovia software, and measurements for TMTV and TLG were recorded. TMTV was calculated using a threshold of 41% of the max pixel value (based on prior studies) to draw the volume of interest (VOI) for a lesion. Pooled t-test was performed to compare TMTV, TLG and COO with EFS at 24 mos. Chi-Square test compared TMTV with COO Results Median age of pts was 58 years, with a median duration of follow up of 26 months. There were 33% with limited stage (Stage I or II) and 67% were advanced stage (Stage III or IV). The mean pretreatment TMTV and pretreatment TLG was 295cm3 and 4519 units. 49% were GCB subtype and 47 % non-GCB. Amongst all patients 19.2 % had an event within 24 mos. When TMTV was compared to EFS at 24 months the mean TMTV was 304 for those who had an event versus 294 without (p=0.95). TLG compared to EFS at 24 months showed a mean TLG of 3391 for those who had an event versus 4914 without (P=0.40). GCB and non-GCB had mean TMTV of 264 and 339 respectively with p =0.59. COO when compared to TLG had means of 4365 and 4933 for GCB and non-GBB respectively with p=0.79.Whereas there was no correlation between stage and COO (p=0.4296) TMTV correlated with Ann Arbor staging (p=0.0002). Conclusion This retrospective study failed to demonstrate a correlation between pre-treatment TMTV, TLG, COO and EFS at 24 months revealing the lack of prognostic significance of pretreatment PET scan derived metrics in DLBCL. Prior studies with TMTV did not evaluate EFS at 24 months as an endpoint and therefore, longer follow up might be needed to demonstrate prognostic significance of pretreatment TMTV minimizing it clinical significance. The different subtypes of DLBCL based on COO as assessed by Hahns algorithm also did not differ in their disease burden as measured by TMTV. Disclosures No relevant conflicts of interest to declare.

The Relationship Between N-Terminal Pro-Brain Natriuretic Peptide Level and Myocardial Performance Index and Their Prognostic Importances in Patients With Acute Myocardial Infarction in Short Term Follow-up

2020 ◽  
Vol 1 (1) ◽  
pp. 12-17
Author(s):  
Mehmet Küçükosmanoğlu ◽  
Cihan Örem
Keyword(s):  
Heart Failure ◽  
Prognostic Significance ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Ejection Time ◽  
Ventricular Ejection Fraction ◽  
Significant Difference ◽  
The Mean ◽  
The Relationship

Introduction: MPI is an echocardiographic parameter that exibit the left ventricular functions globally. NT-proBNP  is an important both diagnostic and prognostic factor in heart failure. In this study, we aimed to investigate the prognostic significance of serum NT-proBNP levels and MPI in patients with STEMI. Method: Totally 104 patients with a diagnosis of STEMI were included in the study. Patients followed for 30-days and questioned for presence of symptoms of heart failure (HF) and cardiac death. Patients were invited for outpatient control after 30-days and were divided into two groups: (HF (+) group) and (HF (-) group). Results: Totally 104 patients with STEMI were hospitalized in the coronary intensive care unit. Of those patients, 17 were female (16%), 87 were male (84%), and the mean age of the patients was 58.9±10.8 years. During the 30-day follow-up, 28 (27%) of 104 patients developed HF. The mean age, hypertension ratio and anterior STEMI rate were significantly higher in the HF (+) group compared to the HF (-) group. Ejection time (ET) and left ventricular ejection fraction (LVEF) were significantly lower and MPI was significantly higher in the HF (+) group. When the values on day first and  sixth were compared, NT-ProBNP levels were decreased in both groups. There was no significant difference between the two groups in terms of the change in MPI values on the first and sixth days. Multiple regression analysis showed that the presence of anterior MI, first day NT-proBNP level and LVEF were independently associated with development of HF and death. Conclusion: In our study, NT-proBNP levels were found to be positively associated with MPI in patients with acute STEMI. It was concluded that the level of NT-proBNP detected especially on the 1st day was more valuable than MPI in determining HF development and prognosis after STEMI.  

scholarly journals Clinical Outcome of Carotid Body Paraganglioma Management: A Review of 10-Year Experience

2020 ◽  
Vol 2020 ◽  
pp. 1-6
Author(s):  
Ahmed Elsayed Fathalla ◽  
Mohammad Ahmad Elalfy
Keyword(s):  
Adjuvant Chemotherapy ◽  
Carotid Artery ◽  
Carotid Body ◽  
Ct Scanning ◽  
Surgical Approaches ◽  
R0 Resection ◽  
Primary Malignancy ◽  
Nerve Paralysis ◽  
The Mean

Background. Carotid body paragangliomas are rare neoplasms usually benign, however sometimes presenting as highly aggressive tumors. Surgery is the main line of treatment. Purpose. To study and describe clinical presentations, surgical approaches, postoperative complications, and treatment outcomes. Materials and Methods. A single-institution retrospective analysis of 19 cases with carotid body paragangliomas who were candidates for surgery from January 2009 through January 2019 with a mean follow-up period of 58.8 months. Results. The mean age was 46 years with the female predominance of 63%. The mean size of the tumor was 4.3 cm. All cases were presented with a painless pulsating neck lump located anteriorly at the level of the hyoid bone. Neck US was done in all cases as a primary screening investigation. CT scanning was the second main investigation performed in 17 cases (89.5%) revealing tumors attached to the carotid artery at its bifurcation. Urinary catecholamine metabolites were measured in all cases to rule out familial functioning types. 5 cases (26.3%) were malignant. All cases were surgically approached through transcervical transverse incision. 11, 5, and 3 cases were classified as Shamblin’s type II, III, and I, respectively. All tumors were R0 resected with nodal neck dissection conducted in the malignant group. Major complications occurred in 4 cases (21%) during tumor dissection from the adventitia of carotid bifurcation. ECA ligation was performed in one case (5.3%). 2 patients (10.5%) suffered XII nerve paralysis. Carotid artery blowout occurred in one patient (5.3%) and was immediately controlled. No operative mortality occurred. All patients were free of disease during the follow-up period. 4 malignant cases (21%) suffered a systemic relapse to bone and lung metastasis justifying adjuvant chemotherapy, radiotherapy, or both. Conclusions. Surgery is the treatment of choice for carotid body paragangliomas. Complete R0 resection should be justified especially in case of malignancy. Adjuvant chemotherapy or radiotherapy is an option for patients with primary malignancy or relapse.

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