Long-term hematologic toxicity of 177Lu-octreotate-capecitabine-temozolomide therapy of GEPNET

2021 ◽  
Author(s):  
Murali Kesavan ◽  
Piyush Grover ◽  
Wei-Sen Lam ◽  
Phillip G Claringbold ◽  
J. Harvey Turner
Keyword(s):  
Cumulative Incidence ◽  
Significant Risk ◽  
Significant Risk Factor ◽  
Baseline Risk ◽  
Hematologic Toxicity ◽  
Gastroenteropancreatic Neuroendocrine Tumors ◽  
Prospective Phase ◽  
Grade 3

Thirty-seven patients with advanced gastroenteropancreatic neuroendocrine tumors (GEPNETs) were treated on a prospective phase II single-center study with 4 cycles of 7.8 GBq 177Lu-octreotate combined with capecitabine and temozolomide chemotherapy (CAPTEM). Each 8-week cycle combined radiopeptide therapy with 14 days of capecitabine (1500 mg/m2) and 5 days of temozolomide (200 mg/m2). The incidence of grade ≥3 hematologic toxicity was analysed. We found that at a median follow-up of 7-years (range 1-10), 6 (16%) patients developed persistent hematologic toxicity (PHT, defined as sustained grade ≥3 hematologic toxicity beyond 36-months follow up) and 3 (8%) developed MDS/AL with a median time-to-event of 46 and 34-months respectively. Estimated cumulative incidence of MDS/AL was 11% (95% CI: 3.45 to 24.01). Development of PHT was the only significant risk factor for secondary (RR, 16; 95% CI: 2.53 to 99.55; p<0.001). The median PFS was 48 months (95% CI: 40.80-55.20) and median OS was 86 months (95% CI: 56.90-115.13). 21 deaths were recorded, including 13 (62%) due to progressive disease and all 3 (14%) patients with MDS/AL. We conclude that 177Lu-octreotate CAPTEM therapy for GEPNETs is associated with a risk of long-term hematologic toxicity. The rising cumulative incidence of MDS/AL >10% mandates for the long-term monitoring of treated patients. However, time to onset is unpredictable and incidence does not correlate with conventional baseline risk factors. Novel methods are required for stratification of prospective patients based on genetic risk.

High-dose imatinib mesylate treatment in patients (Pts) with untreated early chronic phase (CP) chronic myeloid leukemia (CML): 2.5-year follow-up

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 6535-6535 ◽  
Author(s):  
E. Aoki ◽  
H. Kantarjian ◽  
S. O’Brien ◽  
M. Talpaz ◽  
F. Giles ◽  
...  
Keyword(s):  
Standard Dose ◽  
Chronic Phase ◽  
High Dose ◽  
Hematologic Toxicity ◽  
Molecular Response ◽  
Molecular Responses ◽  
Pre Treatment ◽  
Grade 3

6535 Background: The standard dose (SD) of imatinib for CP CML is currently 400 mg daily, but higher doses (HD) may be more effective. We conducted 2 consecutive trials using HD imatinib (i.e., 400mg twice daily) in previously untreated early CP CML pts. This is an updated analysis of the longer follow-up. Methods: A total of 175 previously untreated pts received HD imatinib. We compared the results with a previous study using SD imatinib (400mg/day) in untreated pts with early CP CML (N=50). Results: Cytogenetic and molecular responses were evaluable in 222 pts (N=49 at SD, 173 at HD) and 217 pts (N=46 at SD, 171 at HD), respectively. In HD group, Sokal risk classification was good in 69%, intermediate in 29%, and poor in 11% of pts. There were no differences in pre-treatment characteristics between two groups. The median age was 48 years in both groups. Median follow-up is 53 months for SD and 30 months for HD group. Patients treated with HD had a higher rate of complete cytogenetic responses (90% vs 78% with SD, p=0.03) and these occurred earlier, with 69% achieving this response after 6 months of therapy vs 45% with SD (p=0.001). The cumulative incidence of major molecular response was significantly better in HD group (p=0.03), and this response was also observed earlier in HD group: at 12 months 54% in HD and 24% in SD group had achieved this response (p=0.001). At 24 months, 19/70 (27%) evaluable pts with HD versus 3/31 (10%) of pts in SD group achieved complete molecular remission. Four pts (2%) in HD group and 4 pts (8%) in SD group have progressed to advanced phases (p=0.05). There was a trend in favor of the HD group for transformation-free-survival but it was not statistically significant (p=0.07). Overall survival is excellent in both groups (24 month survival, 99% with HD vs 98% with SD; p=0.24). Grade 3 or 4 hematologic toxicity was more frequent in HD group whereas extramedullary toxicity was similar in two groups. The median actual dose in HD group was 800 mg at 12 months, with 39% patients requiring dose reduction at some point. Conclusions: High-dose imatinib provides higher rates of complete cytogenetic responses and earlier molecular responses with some increase myelosupression. The long-term benefit of earlier responses remains to be demonstrated. [Table: see text]

scholarly journals Risk factors for preoperative and postoperative late seizure in supratentorial meningiomas

2019 ◽  
pp. 316-321
Author(s):  
Rahsan Kemerdere ◽  
Mehmet Yigit Akgun ◽  
Orkhan Alizada ◽  
Sureyya Toklu ◽  
Burak Tahmazoglu ◽  
...  
Keyword(s):  
Risk Factors ◽  
Skull Base ◽  
Surgical Complications ◽  
Significant Risk ◽  
Significant Risk Factor ◽  
Binary Logistic Regression Analysis ◽  
Seizure Outcome ◽  
Long Term Follow Up

Introduction. Seizure following meningioma surgery is common and management may be challenging. Identifying risk factors may help physicians to initiate optimal medical management. The aim of this study is to report seizure outcome and risk factors for perioperative seizure. Materials and Methods. Sixty-three adult patients who underwent supratentorial meningioma resection were included, and perioperative data and long-term follow-up were provided in this retrospective study. Binary logistic regression analysis was used to identify the risk factors for perioperative seizure and postoperative late seizure. Results. The results showed that 20 (37.1 %) patients had preoperative seizure and 10 (50 %) patients were seizure free at the long-term follow-up. Absence of headache was associated with preoperative seizure (p=0.002) while presence of early seizure was significant predictor for postoperative late seizure (p=0.03). Although not significant, occurrence of surgical complications (p=0.08) and non-skull base location (p=0.06) tended toward being a significant risk factor for postoperative late seizure. Conclusion. Presence of early seizures, surgical complications and locations out of skull base may direct postoperative anti-epileptic treatment to decrease seizure incidence which, indeed, increases quality of life for patients with meningioma.

High-Dose (HD) Imatinib Provides Better Responses in Patients with Untreated Early Chronic Phase (CP) CML.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 2143-2143 ◽  
Author(s):  
tsuko Aoki ◽  
Hagop Kantarjian ◽  
Susan O’Brien ◽  
Moshe Talpaz ◽  
Francis Giles ◽  
...  
Keyword(s):  
Cumulative Incidence ◽  
Standard Dose ◽  
Chronic Phase ◽  
High Dose ◽  
Hematologic Toxicity ◽  
Molecular Response ◽  
Grade 3 ◽  
Sequential Trials ◽  
Time Point

Abstract Imatinib (standard dose, SD, 400mg/day) is highly effective in patients with CML in early chronic phase (CP). However, in a phase I study there was clear dose-response correlation and no maximum tolerated dose was identified up to 1000mg/day. Early reports suggested higher response rates with high dose (HD) imatinib (800 mg/day) in this setting. Here we report the long-term follow-up results of high-dose imatinib for patients with CML in early CP. Patients were included from 3 sequential trials: the first included 50 patients all treated with 400mg daily, and 2 subsequent studies included 208 patients all treated at 800 mg daily as the starting dose. There were no differences in pre-treatment characteristics between HD group and SD groups. The median age was 48 years in both groups. Median follow-up was 58 months for SD and 34 months for HD group. Patients treated with HD had a higher rate of complete cytogenetic responses (91% vs 76% in SD group, p=0.002) and these occurred earlier, with 88% achieving a complete cytogenetic response (CGCR) after 6 months of therapy (vs 56% with SD; p<0.00001). The cumulative incidence of major molecular response (MMR) was significantly higher in HD group at 6, 12, 36 and 48 month of follow-up: in HD group, 33%, 58%, 82% and 88% of patients had achieved this response at each time point (vs 2%, 22%, 64% and 67% in the SD group; p<0.00001, <0.00001, 0.01 and 0.002 at respective time point). The cumulative incidence of complete molecular response (CMR) was also significantly higher in HD group at 6, 12, 36 and 48 month of follow-up: in HD group, 8%, 20%, 53% and 66% of patients had achieved this response at each time point (vs 0%, 4%, 27%, and 34% in the SD group; p=0.05, 0.007, 0.003 and 0.0006 at respective time point). Progression-free and transformation-free survivals were significantly better in HD group (p=0.02 and 0.005). Overall survival was excellent in both groups with no difference between them. Grade 3 or 4 hematologic toxicity was more frequent in HD group whereas extramedullary toxicity was similar in both groups. The frequency of ≥ grade 3 anemia, neutropenia and thrombocytopenia in HD group was 12, 35, 29%, respectively while those in SD group were 4, 20, and 12%, respectively. The median actual dose in HD group was 800 mg at 24 months, with only 20% (15/75) of patients taking 400 mg or less at 36 months. We conclude that high-dose imatinib therapy in early CP-CML is associated with higher rates of CGCR, MMR and CMR, and these occur earlier, translating into better progression-free and transformation-free survival. Although HD imatinib is overall well tolerated, there is a higher rate of myelosuppression, most frequently occurring during the first weeks of therapy.

Long-term outcomes after radiosurgery for glomus jugulare tumors

2018 ◽  
Vol 104 (4) ◽  
pp. 300-306 ◽  
Author(s):  
Kita Sallabanda ◽  
Hernan Barrientos ◽  
Daniela Angelina Isernia Romero ◽  
Cristian Vargas ◽  
Jose Angel Gutierrez Diaz ◽  
...  
Keyword(s):  
Univariate Analysis ◽  
Significant Risk ◽  
Significant Risk Factor ◽  
Tumor Control ◽  
High Morbidity ◽  
Glomus Jugulare ◽  
Clinical Control ◽  
Prior Surgery

Aims and background: The treatment of glomus jugulare tumors (GJT) remains controversial due to high morbidity. Historically, these tumors have primarily been managed surgically. The purpose of this retrospective review was to assess the tumor and clinical control rates as well as long-term toxicity of GJT treated with radiosurgery. Methods: Between 1993 and 2014, 30 patients with GJT (31 tumors) were managed with radiosurgery. Twenty-one patients were female and the median age was 59 years. Twenty-eight patients (93%) were treated with radiosurgery, typically at 14 Gy ( n = 26), and 2 patients (7%) with stereotactic radiosurgery. Sixteen cases (52%) had undergone prior surgery. Results: The mean follow-up was 4.6 years (range 1.5–12). Crude overall survival, tumor control, clinical control, and long-term grade 1 toxicity rates were 97%, 97%, 97%, and 13% (4/30), respectively. No statistically significant risk factor was associated with lower tumor control in our series. Univariate analysis showed a statistically significant association between patients having 1 cranial nerve (CN) involvement before radiosurgery and a higher risk of lack of improvement of symptoms (odds ratio 5.24, 95% confidence interval 1.06–25.97, p = .043). Conclusions: Radiosurgery is an effective and safe treatment modality for GJT. Patients having 1 CN involvement before radiosurgery show a higher risk of lack of improvement of symptoms.

scholarly journals In Elderly Patients with CML Second Generation TKIs Are Very Effective and Can be Given Long Term Particularly in the Absence of Comorbidities: A Single Center Experience

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 5455-5455
Author(s):  
Mariella D'Adda ◽  
Elisa Cerqui ◽  
Samantha Ferrari ◽  
Chiara Bottelli ◽  
Angela Passi ◽  
...  
Keyword(s):  
Pleural Effusion ◽  
Hematologic Toxicity ◽  
Single Center ◽  
Single Center Experience ◽  
Line Therapy ◽  
Grade 3 ◽  
Sokal Score ◽  
Tki Treatment

Abstract INTRODUCTION: Second and third generation tyrosine kinase inhibitors (TKIs) are available for Philadelphia positive chronic myeloid leukemia (Ph+ CML) treatment, but though median age at diagnosis is 60-65 years, elderly patients are under-represented in clinical trials concerning 2G-TKIs and a very small number of papers has been published with series of CML patients > 65 years treated with 2G-TKIs or ponatinib. AIM: we have reviewed our single-center experience with 2G-TKIs in chronic-phase CML (CP-CML) patients > 65 years, in first or subsequent therapeutic lines. PATIENTS AND METHODS: the patients were 10 females and 13 males; CML diagnosis had been made between 1994 and 2015 at a median age of 67 years (61-77). According to Sokal score, 3 patients (13%) were classified as low, 15 (65%) as intermediate and 5 (22%) as high-risk respectively. B3a2 transcript was detected in 13 (56%), b2a2 in 10 (44%) cases. Overall, 30 therapies with 2G-TKIs were prescribed in 23 patients CP-CML > 65 years old, from 2007 to 2015. At 2G-TKI therapy start the median age was 68 years (65-79). Charlson Comorbidity Index (CCI) score was 0 in 11 patients, 1 in 4 patients, 2 in 4 patients, 3 in 3 patients and 4 in 1 patient. Thirteen of 23 patients received second-generation TKIs (2G-TKIs) up-front (6 nilotinib, 7 dasatinib), 10/23 patients as 2nd line therapy (6 nilotinib, 4 dasatinib) after imatinib failure (8/10) or intolerance (2/10), median time from imatinib start to 2G-TKIs being 18 months (9-120). Five of 23 patients needed a TKI as 3rd therapeutic line (4 dasatinib, 1 bosutinib), 1 patient also as 4th (ponatinib) and 5th line (bosutinib). RESULTS: all 23 patients are alive after a median follow up of 45 months (12-259) from diagnosis; median follow up from the first 2G-TKI treatment is 36 months (12-110), in details 37 months (12-110) for patients that received 2G-TKIs up front and 34 months (12-70) for patients that received first 2G-TKI as second line therapy. Seventeen of 23 patients (74%) are still on 2G-TKI therapy, with a median treatment of 37 months (12-110) -table 1-. At the last visit 15/17 patients had MMR or best results (1 MR4.5, 9 MR4, 4 MR3). Six patients of 23 (26 %) stopped definitively 2G-TKI therapy, after a median treatment duration of 31 months (6-68) from the first 2G-TKI (table 2), in all cases for non-hematologic toxicity: 1 recurrent pleural effusion (grade 2), 1 geriatric syndrome, 1 carotid atherosclerotic disease, 1 PAOD, 1 vomiting (grade 3) and 1 pulmonary hypertension. At discontinuation, the disease response was MMR (2 patients), MR4 (3 patients), MR 4.5 (1 patient). Hematologic toxicity occurred during 2G-TKI treatment in 7/23 patients (30%), grade 1-2 in 4, grade 3-4 in 3. Sixteen of 23 (69%) patients experienced non-hematologic toxicity, grade 1-2 in 7 (30%) -5/7 pleural effusion-, and grade 3-4 in 9 (39%) -table 3-. There were no significant differences between patients still on therapy and patients that completely discontinued 2G-TKIs regarding Sokal score risk and b2a2/b3a2 transcripts. Conversely, CCI differed in these 2 categories, because CCI was > 1 in 5/6 (83%) of "discontinued" patients and in 7/17 (41%) of "ongoing" patients. Among the eleven patients with CCI = 0, only 1 discontinued 2G-TKI treatment. CONCLUSIONS: Our experience shows that 2G-TKIs are very effective in elderly CP-CML, not only as first line therapy. Non-hematologic toxicity is high and it is the main reason for 2G-TKI discontinuation, that appears to be related to comorbidities. The vast majority of patients without comorbidities remain on 2G-TKI treatment long term. Disclosures No relevant conflicts of interest to declare.

scholarly journals Rituximab-Containing Risk-Adapted Treatment Strategy in Nodular Lymphocyte Predominant Hodgkin Lymphoma: 7-Years Follow-Up

Cancers ◽  
2021 ◽  
Vol 13 (8) ◽  
pp. 1760
Author(s):  
Novella Pugliese ◽  
Marco Picardi ◽  
Roberta Della Pepa ◽  
Claudia Giordano ◽  
Francesco Muriano ◽  
...  
Keyword(s):  
Side Effects ◽  
Hodgkin Lymphoma ◽  
Prognostic Score ◽  
Single Agent ◽  
Response To Therapy ◽  
Baseline Risk ◽  
Historical Cohort ◽  
Treatment Groups

Background: Nodular lymphocyte predominant Hodgkin lymphoma (NLPHL) is a rare variant of HL that accounts for 5% of all HL cases. The expression of CD20 on neoplastic lymphocytes provides a suitable target for novel treatments based on Rituximab. Due to its rarity, consolidated and widely accepted treatment guidelines are still lacking for this disease. Methods: Between 1 December 2007 and 28 February 2018, sixteen consecutive newly diagnosed adult patients with NLPHL received Rituximab (induction ± maintenance)-based therapy, according to the baseline risk of German Hodgkin Study Group prognostic score system. The treatment efficacy and safety of the Rituximab-group were compared to those of a historical cohort of 12 patients with NLPHL who received Doxorubicin, Bleomycin, Vinblastine, Dacarbazine (ABVD) chemotherapy followed by radiotherapy (RT), if needed, according to a similar baseline risk. The primary outcome was progression-free survival (PFS) and secondary outcomes were overall survival (OS) and side-effects (according to the Common Terminology Criteria for Adverse Events, v4.03). Results: After a 7-year follow-up (range, 1–11 years), PFS was 100% for patients treated with the Rituximab-containing regimen versus 66% for patients of the historical cohort (p = 0.036). Four patients in the latter group showed insufficient response to therapy. The PFS for early favorable and early unfavorable NLPHLs was similar between treatment groups, while a better PFS was recorded for advanced-stages treated with the Rituximab-containing regimen. The OS was similar for the two treatment groups. Short- and long-term side-effects were more frequently observed in the historical cohort. Grade ≥3 neutropenia was more frequent in the historical cohort compared with the Rituximab-group (58.3% vs. 18.7%, respectively; p = 0.03). Long-term non-hematological toxicities were observed more frequently in the historical cohort. Conclusion: Our results confirm the value of Rituximab in NLPHL therapy and show that Rituximab (single-agent) induction and maintenance in a limited-stage, or Rituximab with ABVD only in the presence of risk factors, give excellent results while sparing cytotoxic agent- and/or RT-related damage. Furthermore, Rituximab inclusion in advanced-stage therapeutic strategy seems to improve PFS compared to conventional chemo-radiotherapy.

scholarly journals 439 Conservative Versus Surgical Management of Complicated Diverticulitis - A Retrospective Study of Long-Term Outcomes

2021 ◽  
Vol 108 (Supplement_2) ◽  
Author(s):  
E Durity ◽  
G Elliott ◽  
T Gana
Keyword(s):  
Complicated Diverticulitis ◽  
Complication Rates ◽  
Long Term Outcomes ◽  
Female Ratio ◽  
Stoma Reversal ◽  
Group A ◽  
Grade 3 ◽  
Group B

Abstract Introduction Management of complicated diverticulitis has shifted towards a conservative approach over time. This study evaluates the feasibility and long-term outcomes of conservative management. Method We retrospectively evaluated a consecutive series of patients managed with perforated colonic diverticulitis from 2013-2017. Results Seventy-three (73) patients were included with a male to female ratio of 1:2. Thirty-one (31) underwent Hartmann’s procedure (Group A) and 42 patients were managed with antibiotics +/- radiological drainage (Group B). Mean follow-up was 64.9 months (range 3-7 years). CT Grade 3 and 4 disease was observed in 64.5% and 40.4% of Group A and Group B patients, respectively. During follow-up, 9 (21.4%) Group B patients required Hartmann’s. Group A had longer median length of stay compared to Group B (25.1 vs 9.2 days). Post-operative complications occurred in 80.6% with 40% being Clavien-Dindo grade III or higher in group A. Stoma reversal was performed in 8 patients (25.8%). Conclusions In carefully selected cases, complicated diverticulitis including CT grade 3 and 4 disease, can be managed conservatively with acceptable recurrence rates (16.7% at 30 days, 4.8% at 90 days, 19.0% at 5 years). Surgical intervention on the other hand, carries high post-operative complication rates and low stoma reversal rates.

scholarly journals Carbon ion radiotherapy for prostate cancer with bladder invasion

BMC Urology ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yuhei Miyasaka ◽  
Hidemasa Kawamura ◽  
Hiro Sato ◽  
Nobuteru Kubo ◽  
Tatsuji Mizukami ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Locally Advanced ◽  
Therapeutic Benefit ◽  
Carbon Ion Radiotherapy ◽  
Safety And Efficacy ◽  
Carbon Ion ◽  
Grade 3 ◽  
Bladder Invasion

Abstract Background The optimal management of clinical T4 (cT4) prostate cancer (PC) is still uncertain. At our institution, carbon ion radiotherapy (CIRT) for nonmetastatic PC, including tumors invading the bladder, has been performed since 2010. Since carbon ion beams provide a sharp dose distribution with minimal penumbra and have biological advantages over photon radiotherapy, CIRT may provide a therapeutic benefit for PC with bladder invasion. Hence, we evaluated CIRT for PC with bladder invasion in terms of the safety and efficacy. Methods Between March 2010 and December 2016, a total of 1337 patients with nonmetastatic PC received CIRT at a total dose of 57.6 Gy (RBE) in 16 fractions over 4 weeks. Among them, seven patients who had locally advanced PC with bladder invasion were identified. Long-term androgen-deprivation therapy (ADT) was also administered to these patients. Adverse events were graded according to the Common Terminology Criteria for Adverse Event version 5.0. Results At the completion of our study, all the patients with cT4 PC were alive with a median follow-up period of 78 months. Grade 2 acute urinary disorders were observed in only one patient. Regarding late toxicities, only one patient developed grade 2 hematuria and urinary urgency. There was no grade 3 or worse toxicity, and gastrointestinal toxicity was not observed. Six (85.7%) patients had no recurrence or metastasis. One patient had biochemical and local failures 42 and 45 months after CIRT, respectively. However, the recurrent disease has been well controlled by salvage ADT. Conclusions Seven patients with locally advanced PC invading the bladder treated with CIRT were evaluated. Our findings seem to suggest positive safety and efficacy profiles for CIRT.

scholarly journals Cumulative incidence and risk factors for radiation induced leukoencephalopathy in high grade glioma long term survivors

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Robert Terziev ◽  
Dimitri Psimaras ◽  
Yannick Marie ◽  
Loic Feuvret ◽  
Giulia Berzero ◽  
...  
Keyword(s):  
Risk Factors ◽  
Cumulative Incidence ◽  
High Grade Glioma ◽  
High Grade ◽  
Nucleotide Polymorphisms ◽  
Increased Risk ◽  
Radiation Induced ◽  
Long Term Survivors

AbstractThe incidence and risk factors associated with radiation-induced leukoencephalopathy (RIL) in long-term survivors of high-grade glioma (HGG) are still poorly investigated. We performed a retrospective research in our institutional database for patients with supratentorial HGG treated with focal radiotherapy, having a progression-free overall survival > 30 months and available germline DNA. We reviewed MRI scans for signs of leukoencephalopathy on T2/FLAIR sequences, and medical records for information on cerebrovascular risk factors and neurological symptoms. We investigated a panel of candidate single nucleotide polymorphisms (SNPs) to assess genetic risk. Eighty-one HGG patients (18 grade IV and 63 grade III, 50M/31F) were included in the study. The median age at the time of radiotherapy was 48 years old (range 18–69). The median follow-up after the completion of radiotherapy was 79 months. A total of 44 patients (44/81, 54.3%) developed RIL during follow-up. Twenty-nine of the 44 patients developed consistent symptoms such as subcortical dementia (n = 28), gait disturbances (n = 12), and urinary incontinence (n = 9). The cumulative incidence of RIL was 21% at 12 months, 42% at 36 months, and 48% at 60 months. Age > 60 years, smoking, and the germline SNP rs2120825 (PPARg locus) were associated with an increased risk of RIL. Our study identified potential risk factors for the development of RIL (age, smoking, and the germline SNP rs2120825) and established the rationale for testing PPARg agonists in the prevention and management of late-delayed radiation-induced neurotoxicity.

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