Late complications among adult survivors of neuroblastoma in the St. Jude Lifetime Cohort Study (SJLIFE).

10561 Background: Assessment of late outcomes in neuroblastoma survivors has generally consisted of self-reported health events within retrospective cohorts. We aimed to characterize the health outcomes of a clinically-assessed cohort of long-term survivors of neuroblastoma diagnosed between 1963-2003. Methods: In a cohort of 239 ten-year survivors of neuroblastoma, of whom 137 (57%) underwent comprehensive clinical assessments, chronic conditions were graded using a modified version of the Common Terminology Criteria of Adverse Events, version 4.03. Comparisons were made using 272 clinically assessed community controls. Log-binomial regression was used to compare the prevalence of chronic conditions (grade 1-5) between survivors and controls and to calculate prevalence ratio (PR) and 95% confidence intervals (CI). Mean cumulative count (treating death as a competing risk) of chronic conditions by age was used to estimate cumulative burden with imputation of outcomes for non-clinically assessed survivors. Results: The median age at diagnosis was 0.9 (range: 0.0-14.4) and the median age at follow-up was 31.9 (range: 20.2-54.6) years for clinically assessed survivors. Median age of controls was 34.7 (range: 18.3-70.2). Treatment consisted of chemotherapy (75%), radiation (23%) and surgery (91%). Survivors were more likely than controls to have hearing loss (31.4% vs. 2.9%, PR = 10.7, 95% CI = 5.2-22.0), cardiomyopathy (8.8% vs. 0.7%, PR = 11.9, 95% CI = 2.7-52.5), hypothyroidism (10.9% vs. 5.2%, PR = 2.1, 95% CI = 1.1-4.3) or neurological disorders (56.9% vs. 32.4%, PR = 1.8, 95% CI = 1.4-2.2). At 35 years of age, the cumulative incidence of survivors experiencing at least one grade 3-5 condition was 67.3% (95% CI = 58.3-76.0%). By age 35 survivors experienced, on average, 8.5 (95% CI = 7.6-9.3) grade 1-5 and 2.4 (95% CI = 2.0-2.8) grade 3-5 conditions per 100 survivors, which was higher than the burden of grade 1-5 (3.3 [95%CI = 2.9-3.7]) and grade 3-5 (0.9 [95%CI = 0.7-1.0]) conditions identified among controls. Conclusions: Two-thirds of survivors are affected by severe or life-threatening health conditions. Continued follow-up, screening and intervention provide opportunities to optimize health.

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Managing adult Fontan patients: where do we stand?

European Respiratory Review ◽

10.1183/16000617.0091-2016 ◽

2016 ◽

Vol 25 (142) ◽

pp. 438-450 ◽

Cited By ~ 16

Author(s):

Paul Clift ◽

David Celermajer

Keyword(s):

Quality Of Life ◽

Life Expectancy ◽

Fontan Operation ◽

Adult Survivors ◽

Late Complications ◽

Therapeutic Interventions ◽

Palliative Procedure ◽

Fontan Patients

The Fontan operation is performed as a palliative procedure to improve survival in infants born with a functionally univentricular circulation. The success of the operation is demonstrated by a growing adult Fontan population that exists with this unique physiology. Late follow-up has demonstrated expected and unexpected sequelae, and has shown multisystem effects of this circulation. This review discusses the challenges of managing the late complications in terms of understanding this unique physiology and the innovative therapeutic interventions that are being investigated. The challenge remains to maintain quality of life for adult survivors, as well as extending life expectancy.

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Results of photon radiotherapy for unresectable salivary gland tumors: is neutron radiotherapy’s local control superior?

Radiology and Oncology ◽

10.2478/raon-2013-0046 ◽

2014 ◽

Vol 48 (1) ◽

pp. 56-61 ◽

Cited By ~ 16

Author(s):

Daniel E. Spratt ◽

Lucas Resende Salgado ◽

Nadeem Riaz ◽

Michael G. Doran ◽

Moses Tam ◽

...

Keyword(s):

Salivary Gland ◽

Local Control ◽

Late Complications ◽

Salivary Gland Tumors ◽

Salivary Gland Cancer ◽

Low Grade ◽

Severe Toxicity ◽

Grade 3 ◽

Photon Radiotherapy

Abstract Background. The results of RTOG-MRC randomized trial of photon (n=15) versus neutron (n=17) therapy in the 1980’s reported an improved local control (LC) with neutron radiotherapy for unresectable salivary gland tumors. Due to increased severe toxicity with neutron radiotherapy and the paucity of neutron-therapy centers, we analyzed our institution’s results of photon radiotherapy for unresectable salivary gland tumors. Patients and methods. From 1990 to 2009, 27 patients with unresectable salivary gland cancer underwent definitive photon radiotherapy at our institution. Nodal involvement on presentation was found in 9 patients. Median dose of radiotherapy was 70 Gy. Chemotherapy was given to 18 patients, most being platinum-based regimens. Local control (LC), locoregional control (LRC), distant metastasis-free survival (DMFS), overall survival (OS), and toxicity outcomes were assessed. Results. With a median follow-up of 52.4 months, the 2/5-year actuarial LC was 69% (95%CI ± 21.0%)/55% (± 24.2%), LRC was 65% (± 21.4%)/47% (± 21.6%), and DMFS was 71% (± 21.8%)/51% (± 22.8%), respectively using competing risk analysis. The median OS was 25.7 months, and the 2/5-year OS rates were 50% (± 19.0%)/29% (± 16.6%), respectively. Higher histologic grade was significant for an increased rate of DM (intermediate grade vs. low grade, p=0.04, HR 7.93; high grade vs. low grade, p=0.01, HR 13.50). Thirteen (48%) patient’s experienced acute grade 3 toxicity. Late grade 3 toxicity occurred in three (11%) patients. Conclusions. Our data compares favorably to neutron radiotherapy with fewer late complications. Photon radiotherapy is an acceptable alternative to neutron radiotherapy in patients who present with unresectable salivary gland tumors.

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Long-term complications of definitive chemoradiotherapy for esophageal cancer using the classical method

Journal of Radiation Research ◽

10.1093/jrr/rrw078 ◽

2017 ◽

Vol 58 (1) ◽

pp. 106-113 ◽

Cited By ~ 11

Author(s):

Hitoshi Ito ◽

Satoshi Itasaka ◽

Katsuyuki Sakanaka ◽

Norio Araki ◽

Takashi Mizowaki ◽

...

Keyword(s):

Esophageal Cancer ◽

Classical Method ◽

Late Toxicity ◽

Chemoradiation Therapy ◽

Definitive Chemoradiation ◽

Grade 3 ◽

Posterior Field ◽

Long Term Survivors

Abstract Chemoradiation therapy is widely used to treat both inoperable and operable patients, and is less invasive than surgery. Although the number of long-term survivors who have received chemoradiation therapy is increasing, the long-term toxicity pattern and cumulative incidence of toxicity regarding this modality are poorly understood. Classically, chemoradiation therapy for esophageal cancer consists of an anterior–posterior field and a subsequent oblique boost field. We retrospectively analyzed patients who were treated with definitive chemoradiation therapy for esophageal cancer using this classical method from 1999 to 2008. For the assessment of toxicity, the National Cancer Institute Common Toxicity Criteria Version 3.0 was adopted. A total of 101 patients were analyzed. The median follow-up time was 16 months for all patients and 62 months for the surviving patients. Eleven patients experienced late toxicities of ≥Grade 3. Two patients died of late toxicities. The 3- and 5-year cumulative incidences for the first late cardiopulmonary toxicities of ≥Grade 3 were 17.4% and 20.8%, respectively. Cardiopulmonary effusions were observed within the first 3 years of completion of the initial treatment in seven out of eight patients. Sudden death and cardiac ischemia were observed over a 10-year period. Older age was found to be a risk factor for late toxicity after definitive chemoradiation therapy for esophageal cancer. Substantial toxicities were observed in patients who had received chemoradiation therapy for esophageal cancer using the classical method. To minimize the incidence of late toxicity, more sophisticated radiation techniques may be useful.

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Preliminary safety of bevacizumab with first-line Folfox, Capox, Folfiri and capecitabine for mCRC—First B.E.A.Trial

Journal of Clinical Oncology ◽

10.1200/jco.2006.24.18_suppl.3534 ◽

2006 ◽

Vol 24 (18_suppl) ◽

pp. 3534-3534 ◽

Cited By ~ 6

Author(s):

S. R. Berry ◽

D. Cunningham ◽

M. Michael ◽

M. Dibartolomeo ◽

F. Rivera ◽

...

Keyword(s):

Safety Data ◽

Phase Iii ◽

First Line ◽

Community Based ◽

Serious Adverse Events ◽

Life Threatening ◽

Large Phase ◽

Arterial Thromboembolic Events ◽

Grade 3

3534 Background: In a phase III pivotal trial in patients (pts) with metastatic colorectal cancer (mCRC), bevacizumab (BEV) increased overall survival by 30% when added to first-line IFL chemotherapy (CT). Safety data from controlled BEV trials have been described, and indicate that certain serious adverse events (SAE), primarily gastrointestinal (GI) perforations and arterial thromboembolic events (TE) occurred more often in pts who received CT with BEV than those who received CT alone. First BEAT was opened to evaluate safety events of BEV in a broader pt population using a variety of CT regimens. Methods: First BEAT started in June 2004 and aims to enrol up to 2000 mCRC pts in 41 countries. Eligible pts starting with first-line CT (physician’s choice) are treated until progression with BEV (5mg/kg q2w [5FU based CT] or 7.5mg/kg q3w [capecitabine based CT]). SAEs include deaths, new and prolonged hospitalizations, life-threatening as well as medically significant events and are reported within 24 hours. There BEV-relatedness is assessed by investigators. Results: By Dec 20, 2005, 1915 pts had been enrolled in 40 countries. 1603/1915 pts (male 58%; median age 59 years [29% were > 65 years]; PS 0–1 99%) had baseline data available for analyses. Median follow-up was 6.7 months (mean 7.3); 1509 pts had been followed-up for >60 days. The most common first-line CT regimens used with BEV were FOLFOX (28%), CAPOX (17%), FOLFIRI (25%) and capecitabine (8%). Among the 1603 pts that had started treatment with BEV, 638 SAEs were reported in 394 pts (25%). 60-day mortality was 2.4%. The most common SAE were diarrhoea 2.7% and pyrexia 2.2% and were usually not attributed as related to BEV. Related SAEs were reported in 132 (8%) pts. venous TE 1.7%, pulmonary embolism 1.1%, bleeding 1.0%, GI perforation 0.9%, arterial TE 0.8%, hypertension 0.5% wound healing complications 0.3% were usually classified as related SAEs. Conclusions: In this ongoing, large community-based study, the safety profile of BEV in first line mCRC pts receiving a variety of CT regimens, namely FOLFOX, CAPOX, FOLFIRI and capecitabine, appears consistent with that observed in large phase III randomised studies. Updated safety data, including grade 3/4 CTC toxicities, will be presented. [Table: see text]

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Primary prophylactic granulocyte colony-stimulating factor (GCSF) in Gilbert’s disease patients treated with FOLFIRI first line for metastatic colorectal cancer (mCRC): Final results of the FFCD 0604 study.

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.15_suppl.3614 ◽

2013 ◽

Vol 31 (15_suppl) ◽

pp. 3614-3614 ◽

Cited By ~ 1

Author(s):

Thierry Lecomte ◽

Olivier Bouche ◽

Alice oden-Gangloff ◽

Karine Le Malicot ◽

Thomas Aparicio ◽

...

Keyword(s):

Febrile Neutropenia ◽

Hepatic Metastases ◽

Progression Free Survival ◽

Primary Site ◽

High Rate ◽

Molecular Technique ◽

Best Response ◽

Life Threatening ◽

Grade 3

3614 Background: Gilbert’s disease patients (pts) (homozygotous for the UGT1A1*28 allele) have a major risk (>30%) of severe, life-threatening, neutropenia when treated with Irinotecan (IRI). The aim of this study was to demonstrate that, in these pts, treated with IRI 1st line for mCRC, primary prevention with GCSF (lenograstim) reduces under 10% the risk of grade 4 or febrile neutropenia. Methods: This is a prospective, multicenter, phase II study of FOLFIRI + bevacizumab 1st line (IRI 180 mg/m² every 2 weeks) and primary prophylactic GCSF (D5 to D11 each course) in mCRC pts with Gilbert’s disease. Pre-chemotherapy UGT1A1 genotyping was centralized and standardized using a biological molecular technique applied on DNA blood-extracted lymphocytes. Using a 2-step Fleming design, (α=5% and β=90%), 30 pts had to be included with an interim analysis (IA) planned after 20 pts and 4 months of follow-up. Results: Twenty pts from 7 centers were included between 10/2007 and 02/2012 and 19 analysed for the IA. Median pts age was 63 years (range: 45-73), 60% were females, 90% were PS 0 or 1, 80% had a colic primary site and 73% hepatic metastases. The primary site was non- resected in 1/3 of pts. The total number of administered courses of chemotherapy was 229 with a median of 12 per pt (range: 1-40). Among all these courses, 213 were administered with GCSF. IRI was administered as defined by the protocol with a nearly 100% rate of received /theoretical dose. Grade 3 neutropenia rate was 10.5%. No grade 3-4 diarrhea, no grade 4 or febrile neutropenia and no toxic death were observed. No declared SAEs were related to GCSF. In term of best response at 6 months, 7 pts were in complete or partial response and 9 had stable disease. Median progression free survival and overall survival were respectively 8.7 months (4.9; 13.4) and 24.4 months (12.6; ND). Conclusions: This study is the first to demonstrate that a pharmacogenetic approach based on a simple genetic test easy to perform can achieve a high rate of safe and performant administration of IRI in high risk mCRC pts. Clinical trial information: NCT00541125.

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Nerve Anastomosis-our Experience of Thirteen Cases

Bangladesh Journal of Neurosurgery ◽

10.3329/bjns.v9i1.42922 ◽

2019 ◽

Vol 9 (1) ◽

pp. 33-38

Author(s):

Kaisar Haroon ◽

Tania Taher ◽

Shafiul Alam ◽

Abdullah Alamgir ◽

Md Arif Reza ◽

...

Keyword(s):

Observational Study ◽

Peripheral Nerve ◽

Nerve Injury ◽

Motor Function ◽

Peripheral Nerve Injury ◽

Common Condition ◽

Life Threatening ◽

Nerve Anastomosis ◽

Grade 3

Background: Peripheral nerve injury is a common condition. Though it is not life threatening, it may cause disability to a person. In this study we have analysed our experience of anastomosis of injured nerves. Materials and methods: This is an observational study that was done within a period from January 2014 to December 2018. 13 patients with injury to the nerves were operated upon. There were 11 male and 2 female patients. All patients were followed up in OPD upto one and half years. 5 patients were lost from follow up, of these, two were female. Results: After surgery, touch returned in 5 patients. Of motor function,there was no improvement in 1 patient, grade 1 in 1 patient, grade 2 in 4 patients and grade 3 in 3 patients. Those who came earlier had better outcome, so had those with small injury and distal to the limb. Conclusion: peripheral nerve injury has to be repaired as soon as possible. The sooner it can be done the better will be the outcome. Bang. J Neurosurgery 2019; 9(1): 33-38

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Exercise and Risk of Major Cardiovascular Events in Adult Survivors of Childhood Hodgkin Lymphoma: A Report From the Childhood Cancer Survivor Study

Journal of Clinical Oncology ◽

10.1200/jco.2014.56.7511 ◽

2014 ◽

Vol 32 (32) ◽

pp. 3643-3650 ◽

Cited By ~ 89

Author(s):

Lee W. Jones ◽

Qi Liu ◽

Gregory T. Armstrong ◽

Kirsten K. Ness ◽

Yutaka Yasui ◽

...

Keyword(s):

Hodgkin Lymphoma ◽

Adult Survivors ◽

Dependent Manner ◽

Vigorous Exercise ◽

Major Cardiovascular Events ◽

Increased Risk ◽

Vigorous Intensity ◽

Adjusted Rate ◽

Grade 3

Purpose Survivors of Hodgkin lymphoma (HL) are at increased risk of treatment-related cardiovascular (CV) events; whether exercise modifies this risk is unknown. Methods Survivors of HL (n = 1,187; median age, 31.2 years) completed a questionnaire evaluating vigorous-intensity exercise behavior. CV events were collected in follow-up questionnaires and graded according to Common Terminology Criteria for Adverse Events (version 4.03). The primary end point was incidence of any major (grade 3 to 5) CV event. Poisson regression analyses were used to estimate the association between exercise exposure (metabolic equivalent [MET] hours/week−1) and risk of major CV events after adjustment for clinical covariates and cancer treatment. Results Median follow-up was 11.9 years (range, 1.7 to 14.3 years). Cumulative incidence of any CV event was 12.2% at 10 years for survivors reporting 0 MET hours/week−1 compared with 5.2% for those reporting ≥ 9 MET hours/week−1. In multivariable analyses, the incidence of any CV event decreased across increasing MET categories (Ptrend = .002). Compared with survivors reporting 0 MET hours/week−1, the adjusted rate ratio for any CV event was 0.87 (95% CI, 0.56 to 1.34) for 3 to 6 MET hours/week−1, 0.45 (95% CI, 0.26 to 0.80) for 9 to 12 MET hours/week−1, and 0.47 (95% CI, 0.23 to 0.95) for 15 to 21 MET hours/week−1. Adherence to national vigorous intensity exercise guidelines (ie, ≥ 9 MET hours/week−1) was associated with a 51% reduction in the risk of any CV event in comparison with not meeting the guidelines (P = .002). Conclusion Vigorous exercise was associated with a lower risk of CV events in a dose-dependent manner independent of CV risk profile and treatment in survivors of HL.

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Severe/Life-Threatening/Fatal Chronic Health Conditions (CHCs) after Allogeneic Blood or Marrow Transplantation (BMT) in Childhood - a Report from the BMT Survivor Study (BMTSS)

Blood ◽

10.1182/blood-2020-133895 ◽

2020 ◽

Vol 136 (Supplement 1) ◽

pp. 12-13

Author(s):

Anna Sallfors Holmqvist ◽

Yanjun Chen ◽

Jessica Wu ◽

Lindsey Hageman ◽

Kevin D. Battles ◽

...

Keyword(s):

Joint Replacement ◽

Cumulative Incidence ◽

Research Funding ◽

Chronic Gvhd ◽

Health Conditions ◽

Limited Information ◽

Allogeneic Bmt ◽

Life Threatening ◽

Grade 3

Background: Allogeneic BMT is a curative option for children with malignant and non-malignant diseases. Nonetheless, the high intensity of therapeutic exposures at a young age increases the risk of organ compromise and thereby the risk of developing CHCs. Yet, there is limited information regarding CHC risk after allogeneic BMT performed in childhood. We address this gap in patients undergoing allogeneic BMT between 1974 and 2014 at 3 participating transplant centers. Methods: BMT recipients and a sibling comparison group (or the parents of participants <18y) completed a 255-item questionnaire that included sociodemographics and health conditions. A severity score (grades 3 [severe] or 4 [life-threatening]) was assigned to CHCs using CTCAE, v. 5.0. Deceased BMT recipients received a CHC-specific grade 5. Risk of severe/life-threatening CHC in BMT survivors vs. siblings: We calculated the cumulative incidence of CHCs for survivors and siblings as a function of attained age. We used logistic regression for estimating the risk of grade 3-4 conditions in survivors compared to siblings, adjusting for sex, age at study, race/ethnicity, education, household income, and health insurance. Risk of severe/life-threatening/fatal CHC in BMT recipients: We used proportional subdistribution hazards model (Fine-Gray) for competing risks to identify predictors of grade 3-5 CHCs, adjusting for demographics, primary disease, conditioning agents, disease status at BMT and chronic GvHD status. Results: 848 patients had received allogeneic BMT at age ≤22 and survived ≥2y after BMT (563 alive at study; 285 deceased after surviving ≥2y). Primary diagnoses included ALL (29%), AML/MDS (28%), SAA (13%), other (30%); median age at BMT: 11.5y (range: 0.4-22.0); median length of follow-up 10.7y (2.0-41.4). Risk of severe/life-threatening CHC in 563 BMT survivors vs. 515 siblings: Cumulative incidence of grade 3-4 condition by age 30y among BMT recipients was significantly higher than that among siblings (38.5±2.7% vs. 5.4±1.0%, p<0.0001), Figure 1. The adjusted odds of developing grade 3-4 CHCs were 8.9-fold higher in BMT survivors (95%CI 6.4-12.5). Higher odds were observed for developing cataracts (OR=48.2; 95%CI 17.9-129.5), heart disease (OR=11.4, 95%CI, 3.9-33.3), diabetes (OR=11.1; 95%CI 3.5-34.8), thyroid nodules (OR=6.6, 95%CI, 2.6-17.0), joint replacement (OR=4.4, 85%CI, 1.7-10.9), and sensorineural disorders (hearing loss/balance disorder/legally blind); OR=3.2, 95%CI, 1.5-6.8). Risk of severe/life-threatening/fatal CHCs in 848 BMT recipients: cumulative incidence of grades 3-5 CHCs was 60.5±3.0% at 40y (Figure 2). The most prevalent grade 3-5 CHCs were second malignancy (11.8%), cataract (5.9%), cardiovascular disease (5.8%), sensorineural disorder (4.4%), diabetes (3.4%), and joint replacement (2.9%). The risk of grades 3-5 CHCs was higher among females (HR=1.3, 95%CI 1.0-1.6), age >12y at BMT (HR=1.4, 95%CI 1.1-1.8) and among those exposed to TBI (HR=1.7, 95%CI 1.2-2.3). Conclusions: Two-year survivors of allogeneic BMT performed in childhood had an almost 10-fold higher risk of severe/life-threatening CHCs compared to siblings. By age of 30, 39% of the survivors had developed a severe or life-threatening CHC. The results of the present study call for close follow-up, from the time of transplantation continuing throughout life. Disclosures Weisdorf: Incyte: Research Funding; FATE Therapeutics: Consultancy. Arora:Fate Therapeutics: Consultancy; Syndax: Research Funding; Kadmon: Research Funding; Pharmacyclics: Research Funding.

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Burdern of Long-Term Morbidity after Hematopoietic Cell Transplantation: A Report from the Bone Marrow Transplant Survivor Study (BMTSS).

Blood ◽

10.1182/blood.v110.11.832.832 ◽

2007 ◽

Vol 110 (11) ◽

pp. 832-832 ◽

Cited By ~ 2

Author(s):

Can-Lan Sun ◽

Liton Francisco ◽

Toana Kawashima ◽

Leslie L. Robison ◽

K.S. Baker ◽

...

Keyword(s):

Health Condition ◽

Chronic Health Conditions ◽

Health Conditions ◽

Unrelated Donor ◽

Chronic Health ◽

Threatening Condition ◽

Life Threatening ◽

Grade 3

Abstract Long-term survival is an expected outcome after HCT. However, no study has assessed the burden of long-term morbidity in these survivors, or attempted to identify subpopulations at highest risk for severe, debilitating conditions. In this study, we determined the prevalence and severity of chronic health conditions in a large population of long-term HCT survivors and compared these outcomes with their siblings. BMTSS, a collaborative effort between City of Hope National Medical Center and University of Minnesota, examined self-reported chronic health conditions in individuals who underwent HCT between 1976 and 1998, and survived two or more years. A severity score (grade 1 through 4, ranging from mild to life-threatening or disabling) was assigned to each health condition according to the Common Terminology Criteria for Adverse Events (version 3). A partial list of conditions graded as severe or life-threatening (grade 3 or 4) included congestive heart failure, second malignant neoplasms, coronary artery disease, cerebrovascular accident, renal failure/dialysis/renal transplant, and active chronic graft vs. host disease. Adverse psychosocial outcomes were not included. Cox proportional-hazard models were used to estimate hazard ratios and their 95% confidence intervals. We compared the prevalence and severity of chronic conditions in 1013 HCT survivors (455 autologous, 460 related donor, and 98 unrelated donor HCT survivors) with 309 siblings. The median age at study participation was 44 (range 18–73) and 45 years (range 17–79) for survivors and siblings, and the median follow-up for the survivors was 7.3 years (range 2–28) from HCT. Among the 1013 survivors, 69% had at least one chronic condition, and 29% had a severe or life-threatening condition (grade 3 or 4). The comparable figures in siblings were 39% and 7%, respectively (p<0.001 compared to survivors). After adjustment for age at HCT, sex and race/ethnicity, survivors were 2.4 times as likely as their siblings to develop any chronic health conditions (95%CI, 2.0–2.9), and 4.5 times more likely to develop severe/life threatening conditions (95%CI, 3.0–6.7). Groups at highest risk for a severe or life-threatening condition are summarized in the Table. Among survivors, the cumulative incidence of a chronic health condition reached 84% at 20 years post HCT, with a cumulative incidence of 55% for severe/life threatening conditions at 15 years after HCT. The chronic health burden of this population is significant, and life-long follow-up of patients who receive transplantation is recommended. Table: Groups at highest risk for severe or life-threatening condition Risk Factors Relative Risk 95% CI Siblings 1.0 __ CML 5.8 3.8–8.9 AML 4.9 3.2–7.5 ALL 5.2 3.3–8.3 Allogeneic sibling donor 5.9 3.9–8.7 Unrelated donor 7.4 4.9–11.1 TBI 5.0 3.4–7.5

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Capecitabine and oxaliplatin as first-line chemotherapy in patients with metastatic colorectal carcinoma

Journal of Clinical Oncology ◽

10.1200/jco.2006.24.18_suppl.13578 ◽

2006 ◽

Vol 24 (18_suppl) ◽

pp. 13578-13578

Author(s):

C. Gennatas ◽

V. Michalaki ◽

S. Gennatas ◽

A. Kondi-Paphiti ◽

D. Voros ◽

...

Keyword(s):

Progression Free Survival ◽

Complete Response ◽

First Line ◽

Free Survival ◽

Life Threatening ◽

Baseline Characteristics ◽

Grade 3 ◽

Unacceptable Toxicity ◽

Line Chemotherapy

13578 Background: Capecitabine is an oral fluoropyrimidine with superior activity and safety compared with bolus 5-FU/LV in metastatic colorectal cancer (CRC). The aim of this study was to evaluate the efficacy and safety of a combination of capecitabine and oxaliplatin as first-line chemotherapy in patients with advanced CRC. Methods: Fourty-six patients (26 men and 20 women) with metastatic CRC entered this study. All patients were treated with capecitabine (1,000mg/m2 p.o.twice daily, days 1–14) and oxaliplatin (130mg/m2 on day 1). Cycles were repeated every 21 days until disease progression or unacceptable toxicity. Baseline characteristics: Median age 61 years (range 32–74), main sites of metastasis: Liver 32 patients (70%), liver and lungs 4 patients (9%), lungs 3 patients (6%), other sites 7 patients (15%). Results: 2 patients (4%) achieved complete response (CR), 17 patients (37%) achieved partial response (PR) and 7 patients (15%) attained stable disease (SD). With a median follow-up of 22 months the progression free survival was 7.5 months and overall survival was 19.0 months. All patients were assessable for toxicities. The most commonly encountered adverse events were from the gastrointestinal system (all grades 48%, grade 3, 6%). Neither toxic death nor life-threatening febrile neutropenia were reported. Conclusions: The combination of capecitabine and oxaliplatin is a convenient regimen in patients with advanced CRC that is associated with considerable efficacy and limited toxicity. No significant financial relationships to disclose.

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