Safety and Feasibility Analysis of a Prospective Trial on Stereotactic Body Radiotherapy for Solitary Bone Plasmacytoma

2021 ◽  
pp. 1-6
Author(s):  
Geovanne Pedro Mauro ◽  
Pedro Pereira Neffá ◽  
Rosangela Correa Villar ◽  
Gracia Aparecida Martinez ◽  
Heloísa de Andrade Carvalho
Keyword(s):  
Stereotactic Body Radiotherapy ◽  
Retrospective Cohort ◽  
Standard Dose ◽  
Prospective Trial ◽  
Local Progression ◽  
Eortc Qlq C30 ◽  
Solitary Bone Plasmacytoma ◽  
Skull Base Lesions ◽  
Grade 3 ◽  
Eortc Qlq

<b><i>Background:</i></b> There have been reports on the use of hypofractionated stereotactic body radiotherapy (SBRT) for bone plasmacytomas, but no prospective data are available. We present the initial analysis of an ongoing prospective protocol on SBRT addressing the feasibility and safety of this treatment for solitary bone plasmacytomas. <b><i>Patients and Methods:</i></b> A prospective cohort of SBRT for solitary bone plasmacytoma was developed. Patients could receive different doses depending on the index bone, from single fraction for skull base lesions, 24 Gy in 3 fractions for spine lesions, and 30 Gy in 5 fractions for other bones. Overall survival, bone events, local control, and progression to multiple myeloma (MM) were measured and compared to our retrospective cohort of patients treated with conformal standard-dose radiotherapy. Quality of life was assessed via the EORTC QLQ-C30 questionnaire, and toxicities were assessed by the CTCAE v5.0 criteria. After 1 year or the inclusion of 5–10 patients, a feasibility and safety analysis was programmed. <b><i>Results:</i></b> Between April 2018 and April 2019, 5 patients were included. All were male, with a median age of 53.1 years. The median follow-up was 21.8 months. No patient had local progression, bone event, or died. Two patients had progressions to MM. The mean survival free of progression to MM was 18.6 months, compared to 19 months in the retrospective cohort; median values were not reached. There were no grade 3 toxicities. <b><i>Conclusion:</i></b> SBRT for plasmacytoma is safe and feasible. More robust data are awaited.

scholarly journals Impact of Pressurized Intraperitoneal Aerosol Chemotherapy on Quality of Life and Symptoms in Patients with Peritoneal Carcinomatosis: A Retrospective Cohort Study

2017 ◽  
Vol 2017 ◽  
pp. 1-10 ◽  
Author(s):  
Hugo Teixeira Farinha ◽  
Fabian Grass ◽  
Amaniel Kefleyesus ◽  
Chahin Achtari ◽  
Benoit Romain ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cohort Study ◽  
Peritoneal Carcinomatosis ◽  
Retrospective Cohort ◽  
Negative Impact ◽  
Peritoneal Cancer ◽  
Before And After ◽  
Eortc Qlq C30 ◽  
Eortc Qlq

Background. Peritoneal cancer treatment aims to prolong survival, but preserving Quality of Life (QoL) under treatment is also a priority. Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) is a novel minimally invasive repeatable treatment modality. The aim of the present study was to assess QoL in our cohort of PIPAC patients. Methods. Analysis of all consecutive patients included from the start of PIPAC program (January 2015). QoL (0–100: optimal) and symptoms (no symptom: 0–100) were measured prospectively before and after every PIPAC procedure using EORTC QLQ-C30. Results. Forty-two patients (M : F = 8 : 34, median age 66 (59–73) years) had 91 PIPAC procedures in total (1 : 4x, 17 : 3x, 12 : 2x, and 12 : 1x). Before first PIPAC, baseline QoL was measured as median of 66±2.64. Prominent complaints were fatigue (32±4.3) and digestive symptoms as diarrhea (17±3.75), constipation (17±4.13), and nausea (7±2.54). Overall Quality of Life was 64±3.75 after PIPAC#1 (p=0.57), 61±4.76 after PIPAC#2 (p=0.89), and 70±6.67 after PIPAC#3 (p=0.58). Fatigue symptom score was 44±4.86 after PIPAC#1 and 47±6.69 and 34±7.85 after second and third applications, respectively (p=0.40). Diarrhea (p=0.31), constipation (p=0.76), and nausea (p=0.66) did not change significantly under PIPAC treatment. Conclusion. PIPAC treatment of peritoneal carcinomatosis had no negative impact on patients’ overall QoL and its components or on main symptoms. This study was registered online on Research Registry (UIN: 1608).

Safety and efficacy of accelerated hypofractionation and stereotactic body radiotherapy for hepatocellular carcinoma in the setting of advanced liver dysfunction.

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 403-403
Author(s):  
Nima Nabavizadeh ◽  
Joseph Waller ◽  
Robert Fain ◽  
Yiyi Chen ◽  
Catherine Degnin ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Local Control ◽  
Liver Dysfunction ◽  
Stereotactic Body Radiotherapy ◽  
Effective Treatment Option ◽  
Local Progression ◽  
Grade 5 ◽  
Secondary Endpoints ◽  
Critical Organ ◽  
Grade 3

403 Background: To report toxicities and outcomes for stereotactic body radiotherapy (SBRT) and accelerated hypofractionated radiotherapy (AHRT) in patients with Child-Pugh (CP) A/B/C and Albumin-Bilirubin (ALBI) score 1/2/3 hepatocellular carcinoma (HCC). Methods: We retrospectively reviewed 151 patients with HCC treated with SBRT (50 Gy in 5 fractions) or AHRT (45 Gy in 18 fractions) between 2007 and 2015. Primary endpoint was incidence of grade 3 or higher toxicities within 6 months of radiotherapy (RT). Patients were censored for toxicity upon local progression, further liver-directed therapy, or if they exhibited grade 3 or higher toxicities prior to RT, unless RT elevated the grading or a new toxicity class was observed. Secondary endpoints of overall survival and local control were calculated. Results: Median follow-up was 11 months (1 – 90 months). Most received SBRT (72%), while 28% received AHRT due to size criteria ( > 5 cm) or proximity to a critical organ-at-risk. Grade 3 or higher hyperbilirubinemia and hypoalbuminemia was greater in the CP-B8/B9/C patients (42% and 22%) or ALBI-3 patients (45% and 31%) compared to patients with CP-A/B7 (11% and 4%, p < 0.001) or ALBI-1/2 (14% and 4%, p < 0.001). For all other toxicity classes, no difference between liver functionality groups was seen. Eleven grade 4 and no grade 5 toxicities were observed. For all pts, 1- and 2-year treated-lesion local control (LC) rates were greater for SBRT as compared to AHRT (2-year LC 95% vs. 66%, p < 0.0001). When excluding patients with planning treatment volumes > 115 cc (equivalent to a 6 cm sphere), SBRT still yielded superior outcomes. Conclusions: Other than higher rates of grade 3+ hypoalbuminemia and hyperbilirubinemia, highly conformal RT appears to be a potentially safe and effective treatment option for HCC patients with advanced liver dysfunction. Compared to AHRT, SBRT is associated with superior local control.

Phase II trial of SM-88 in patients with metastatic pancreatic cancer: Preliminary results of the first stage.

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 200-200 ◽  
Author(s):  
Marcus Smith Noel ◽  
Andrea Wang-Gillam ◽  
Allyson J. Ocean ◽  
Sant P. Chawla ◽  
Giuseppe Del Priore ◽  
...  
Keyword(s):  
Oxidative Stress ◽  
Single Agent ◽  
High Dose ◽  
Tumor Cell Death ◽  
Neutrophil Lymphocyte Ratio ◽  
Initial Stage ◽  
Cyp3a4 Inducer ◽  
Eortc Qlq C30 ◽  
Grade 3 ◽  
Eortc Qlq

200 Background: SM-88 (tyrosine derivative [Td], mTOR inhibitor, CYP3a4 inducer and oxidative stress catalyst) is a relatively non-toxic, targeted therapy that utilizes the Warburg Effect in combination with oxidative stress to cause tumor cell death. It is well suited for pancreas cancer because of its ability to penetrate tumors and be tolerated by debilitated patients. Methods: Patients progressed on at least one line of chemotherapy are eligible for either low versus high dose single agent SM-88 in the dose selecting first stage of this trial. The primary endpoint of the study is response rate by BICR (NCT03512756). Results: As of Sept 23, 36 subjects with initial stage II 26%, III 33%, or IV 41%, were randomized between an active Td dose (430 mg/d) and 920 mg/d. Mean age was 64.9 (45.6 - 84.1); BMI 24.2 (16.8 - 36.7); female 45.5%, white 93.1%, black 4.5%; median of 3 prior lines (range 1 - 6); baseline median albumin, neutrophil lymphocyte ratio, alk phos and 19.9 were 3.8 g/dl (2.6 - 9.6), 4 (1 - 141), 179.5 (54 - 661) and 5089 (4 - 651, 696) respectively. The regimen was well tolerated with no treatment related grade 4 or 5 events; 55.6% of treated subjects (20/36) had 94 AEs, with 18.0% (17/94) being at least possibly treatment related, of which three were grade 3 (arthralgia, fatigue and asthenia). CTCs at baseline were detected in 97% (mean 93.1 cells/4 ml) and fell in 69% (11/16) evaluable subjects from 141.4 to a nadir of 30.7/4 ml (median reduction 77% [3% - 97%]). 22.2% (2/9) evaluable subjects showed CA19.9 declines, both of which also showed CTC declines. 83% of subjects have remained on treatment a median of 4.7 wks (1 - 18.7); 6 were eligible for the initial scheduled assessment at 2 months; 3 of 4 evaluable subjects (75%) had RECIST or PET SUV responses. Lesion SUVs decreased an average of 24.1% (8.3 - 35.7%). EORTC QLQ-C30, -PAN26 and correlative assays were obtained including IGF, leptin, genomics, NLR, and others. Conclusions: SM-88 has demonstrated unconfirmed monotherapy efficacy signals with no meaningful toxicity in a preliminary assessment of this ongoing trial. With additional follow up a dose will be selected for expansion Clinical trial information: NCT03512756.

Double Transplantation with Melphalan (200 mg/m2) Compared with Triple Transplantation with Intermediate Dose Melphalan (100 mg/m2) in Patients with Multiple Myeloma

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 3317-3317
Author(s):  
Heinz Ludwig ◽  
Ivan Spicka ◽  
Werner Linkesch ◽  
Richard Greil ◽  
Hedwig Kasparu ◽  
...  
Keyword(s):  
Response Rates ◽  
Hematological Toxicity ◽  
Similar Response ◽  
Similar Treatment ◽  
Kaplan Meier ◽  
Survival Endpoints ◽  
Eortc Qlq C30 ◽  
Grade 3 ◽  
Eortc Qlq ◽  
Intermediate Dose

Abstract Previous studies showed a survival advantage of double over single transplantation in proportion of patients. In this study we aimed to explore whether triple transplantation with intermediate melphalan 100mg/m2 (M100) yields at least similar treatment results with less toxicity than double transplantation with melphalan 200mg/m2 (M200). 219 Patients were entered in the study and started on 3 cycles of VAD induction therapy followed by IEV (ifosfamide (2g/m2)-etoposide (150mg/m2), d1-3; epirubicin (50mg/m2) d1) and G-CSF (5mg/kg) from d4 for stem cell priming and collection. Thereafter, 178 patients were randomized to either double or triple transplantation with M200 or M100. Reasons for non-randomization were PD (n=21), toxic side effects during induction or insufficient mobilization (n=9), withdrawal of consent (n=3), too early (n=1), death (n=1), second neoplasia (n=1), protocol violation (n=2), other (n=3). Patients achieving better than PD had subsequently been randomized to prednisolone plus interferon-a2b (Schering Plough) 3MU TIW or to interferon only maintenance therapy. Median age was 58 years (range: 27–71 years, n=172). DS stage I: 7%, stage II: 18%, stage III: 75%, M-component: IgG: 60%, IgA: 24%, IgD: 1%, IgM: 1%, light chain: 11%, non-secretory:1%. QoL was assessed with the EORTC QLQ C30 instrument. Chi2 test for trend was used for comparison of response and survival endpoints were estimated by the Kaplan-Meier product limit method. Median follow up is 34 months. Response rates in 186 patients evaluable for response after VAD (≥ 2 cycles of VAD) were: CR: 10%, PR: 58%, SD: 21% and PD: 11%. Median time from start of VAD to start of transplantation was 141 in the double and 144 days in the triple transplantation arm. Response rates after transplantation did not differ between pts treated with double or triple transplantation (CR: 41% vs. 41%, PR: 50% vs. 49%, SD 8% vs. 8%, PD: 1% vs. 3%, p=0.91. Median PFS for both groups combined was 39 mos, but showed a tendency for shorter PFS in pts on triple transplantation (median 44 mos. vs. 38 mos; HR 1.18, 95% CI: 0.77–1.81, p=0.22). Median OS has not been reached as yet, but did not differ between both groups with 3-year rates of 85% and 81%, respectively, and a HR of 1.01. Except for more cases of grade 1 and 2 anemia in the triple transplantation arm, hematological toxicity was similar in both groups. There was a tendency for more grade 2–3 mucositis and grade 3–4 vomiting, nausea in the double transplantation group. In conclusion, triple transplantation with intermediate dose M resulted in similar response rates, slightly shorter PFS but similar OS and was associated with less mucositis and slightly less vomiting, and nausea. Figure Figure

The impact of infection on health-related quality of life (HRQoL) in patients with Philadelphia negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (Ph- R/R BCP ALL) in a randomized, open-label, phase 3 study (TOWER).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e18511-e18511
Author(s):  
Andre C. Schuh ◽  
Yan Li ◽  
Max S. Topp ◽  
Xinke Zhang ◽  
Paul Cannell ◽  
...  
Keyword(s):  
Lymphoblastic Leukemia ◽  
Standard Of Care ◽  
Minimum Clinically Important Difference ◽  
Open Label ◽  
Phase 3 ◽  
Point Change ◽  
Eortc Qlq C30 ◽  
Grade 3 ◽  
Eortc Qlq ◽  
The Impact

e18511 Background: In the phase 3 TOWER study (NCT02013167), blinatumomab (BLIN) significantly improved overall survival in adults with Ph- R/R BCP ALL, and these patients (pts) also reported better HRQoL (EORTC QLQ-C30 measures) compared with standard of care (SOC) chemotherapy. This analysis assessed the impact of grade 3+ infection, which was reported in 34.1% of BLIN pts vs 52.3% of SOC pts, on HRQoL in TOWER. Methods: Pts were stratified into two groups: those with infection vs those without infection, between baseline and Day 8, Day 15, and Day 29. A difference-in-difference (DID) model investigated the impact of infection on HRQoL. A 5-point change is considered the minimum clinically important difference in the EORTC QLQ-C30 for between group comparisons (King et al. 1996). Results: In total, 342 pts (n = 247 BLIN; n = 95 SOC) had a non-missing baseline and ≥1 post-baseline HRQoL score for any scale. Grade 3+ infection was reported in 15 (4.5%) pts before Day 8, 49 (14.5%) pts before Day 15, and 76 (22.6%) pts before Day 29. Pts with grade 3+ infection reported clinical meaningful deterioration in global health status (GHS) score and in almost all functional subscales across timepoints assessed (Table). At Day 29, grade 3+ infection was associated with statistically significant and clinically meaningful deterioration in GHS and most functional scales (Table). Similar but smaller effects were also observed for symptom scales/items (data not shown). Conclusions: Grade 3+ infection in pts with Ph- R/R BCP ALL was associated with clinically meaningful deterioration in HRQoL. The lower incidence of infection in pts treated with BLIN vs SOC may have contributed to the improved HRQoL for pts treated with BLIN. Clinical trial information: NCT02013167. [Table: see text]

CCTG CO.26 trial: A phase II randomized study of durvalumab (D) plus tremelimumab (T) and best supportive care (BSC) versus BSC alone in patients (pts) with advanced refractory colorectal carcinoma (rCRC).

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 481-481 ◽  
Author(s):  
Eric Xueyu Chen ◽  
Derek J. Jonker ◽  
Hagen F. Kennecke ◽  
Scott R. Berry ◽  
Felix Couture ◽  
...  
Keyword(s):  
Cytotoxic T Lymphocyte ◽  
Human Monoclonal Antibody ◽  
Randomized Study ◽  
Progression Free Survival ◽  
Best Supportive Care ◽  
P Value ◽  
Synergistic Activity ◽  
Eortc Qlq C30 ◽  
Grade 3 ◽  
Eortc Qlq

481 Background: D is a human monoclonal antibody (mAb) that inhibits binding of programmed cell death ligand 1 (PD-L1) to its receptor. T is a mAb against the cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Targeting both PD-L1 and CTLA-4 may have additive/synergistic activity as the mechanisms of action of CTLA-4 and PD-L1 inhibition are non-redundant. This study evaluated whether combining PD-L1 and CTLA-4 inhibition would lead to improved pt survival vs BSC alone in rCRC. Methods: Pts with rCRC were randomized 2:1 to D+T vs BSC . Pts were eligible if they failed all standard regimens; containing a fluoropyrimidine, irinotecan and oxaliplatin (and an EGFR inhibitor if Ras wild type). Prior treatment (Tx) with anti-VEGF agents or TAS-102 was permitted but not mandatory. Tx consisted of D (1500 mg) D1 q 28 days and T (75 mg) D1 for first 4 cycles, and all appropriate supportive measures. Primary endpoint was overall survival (OS) and a two-sided p-value < 0.10 was considered statistically significant. Results: Between August 2016 and June 2017, 180 pts were enrolled and 179 treated as randomized. Pt baseline characteristics were balanced. 85% of pts received ≥ 90% of planned doses of D and T. No pts with known defective mismatch repair (dMMR) tumors were enrolled. With a median (med) follow-up of 15.2 months (mo), the med OS was 6.6 mo for D+T and 4.1 mo for BSC (p = 0.07; Hazard ratio (HR): 0.72, 90% confidence interval (CI): 0.54–0.97). Med progression free survival was 1.8 mo and 1.9 mo respectively (HR 1.01, 90% CI 0.76–1.34; p=0.97). Disease control rate was 22.7% for D+T and 6.6% for BSC (p = 0.006). Grade 3/4 abdominal pain, fatigue, lymphocytosis and eosinophilia were significantly higher in D+T. At 16 weeks, there was significantly less deterioration on EORTC QLQ-C30 physical function for D+T. Confirmation of MMR status is ongoing. Conclusions: D+T significantly prolonged OS in pts with rCRC and preserved quality of life. Adverse events were more frequent with D+T. This is the first study showing that combined PD-L1 and CTLA-4 inhibition prolongs survival in pts with advanced refractory CRC not selected for dMMR. Clinical trial information: NCT02870920.

scholarly journals Outcomes After Stereotactic Body Radiotherapy or Radiofrequency Ablation for Hepatocellular Carcinoma

2016 ◽  
Vol 34 (5) ◽  
pp. 452-459 ◽  
Author(s):  
Daniel R. Wahl ◽  
Matthew H. Stenmark ◽  
Yebin Tao ◽  
Erqi L. Pollom ◽  
Elaine M. Caoili ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Radiofrequency Ablation ◽  
Tumor Size ◽  
Stereotactic Body Radiotherapy ◽  
Treatment Options ◽  
Local Treatment ◽  
Maximum Diameter ◽  
Underlying Liver Disease ◽  
Local Progression ◽  
Grade 3

Purpose Data guiding selection of nonsurgical treatment of hepatocellular carcinoma (HCC) are lacking. We therefore compared outcomes between stereotactic body radiotherapy (SBRT) and radiofrequency ablation (RFA) for HCC. Patients and Methods From 2004 to 2012, 224 patients with inoperable, nonmetastatic HCC underwent RFA (n = 161) to 249 tumors or image-guided SBRT (n = 63) to 83 tumors. We applied inverse probability of treatment weighting to adjust for imbalances in treatment assignment. Freedom from local progression (FFLP) and toxicity were retrospectively analyzed. Results RFA and SBRT groups were similar with respect to number of lesions treated per patient, type of underlying liver disease, and tumor size (median, 1.8 v 2.2 cm in maximum diameter; P = .14). However, the SBRT group had lower pretreatment Child-Pugh scores (P = .003), higher pretreatment alpha-fetoprotein levels (P = .04), and a greater number of prior liver-directed treatments (P < .001). One- and 2-year FFLP for tumors treated with RFA were 83.6% and 80.2% v 97.4% and 83.8% for SBRT. Increasing tumor size predicted for FFLP in patients treated with RFA (hazard ratio [HR], 1.54 per cm; P = .006), but not with SBRT (HR, 1.21 per cm; P = .617). For tumors ≥ 2 cm, there was decreased FFLP for RFA compared with SBRT (HR, 3.35; P = .025). Acute grade 3+ complications occurred after 11% and 5% of RFA and SBRT treatments, respectively (P = .31). Overall survival 1 and 2 years after treatment was 70% and 53% after RFA and 74% and 46% after SBRT. Conclusion Both RFA and SBRT are effective local treatment options for inoperable HCC. Although these data are retrospective, SBRT appears to be a reasonable first-line treatment of inoperable, larger HCC.

Results of a longitudinal survey on quality of life (QoL) in 935 patients with supradiaphragmatic early stage Hodgkin lymphoma (HL) enrolled in the EORTC-GELA H8 trial (# 20931)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 8582-8582
Author(s):  
N. Heutte ◽  
N. Mounier ◽  
H. Flechtner ◽  
A. M. Mellink ◽  
J. H. Meerwaldt ◽  
...  
Keyword(s):  
Treatment Duration ◽  
Negative Impact ◽  
Early Stage ◽  
Disease Free Survival ◽  
Eortc Qlq C30 ◽  
Grade 3 ◽  
Eortc Qlq ◽  
Involved Field ◽  
The Impact

8582 Background: To study the change in posttreatment QoL and fatigue in patients with supradiaphragmatic early stage HL. Methods: QoL assessment was made using the EORTC QLQ-C30 core questionnaire and fatigue was assessed using the MFI-20 questionnaire. Questionnaires were given immediately after treatment completion and every 6 months thereafter for at least a period of 5 years. Mixed models (Med Decis Making 2003;3:54–66) were used to assess statistically reliable changes of the variables tested with time because they allow unequal number of assessments per patients. Variables tested were the 7 functioning scales and the fatigue scale of the QLQ-C30 questionnaire, the 5 MFI-20 fatigue scales, and time using 6 time periods: 0–6, 7–14, 15–21, 22–32, 33–47, ≥48 months following the end of treatment. The impact of gender, age (<30, 30–49, ≥50 years), treatment (mantle-field irradiation, subtotal nodal irradiation (STNI), 3, 4 or 6 MOPP-ABV and involved-field irradiation or 4 MOPP-ABV and STNI) and treatment-related acute grade 3–4 toxicity was also tested. Patients were censored at relapse when occurred. Results: Of the 1577 patients enrolled in the trial (1993–1998), 935 (59%, median follow-up 7 years) participated for a total of 3,227 assessments. Main clinical characteristics did not differ between patients with missing QoL forms and those with complete data. There were no significant differences in disease-free survival between treatment arms. Significant (P<0.001) improvement with time was observed for all QoL and fatigue variables tested. Overall, young age and male sex significantly (P<0.01) correlated with improvement in all QLQ-C30 dimensions except cognitive functioning. Treatment duration ≥6 months had a significant (P<0.005) negative impact on global QoL. Age≥30 years and treatment duration ≥2 months negatively (P<0.05) influenced MFI-20 variable changes. Previous toxicity and age ≥30 years altered mental fatigue and motivation. Conclusions: QoL data from the reintegration process of patients into normal life during the first follow-up years show substantial limitations. The impact of treatment is limited. Fatigue remains of great concern in these patients. No significant financial relationships to disclose.

Variation in health-related quality of life (HRQoL) during chemotherapy for advanced non-small cell lung cancer.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 9562-9562
Author(s):  
Bjørn Henning Grønberg ◽  
Sveinung Sørhaug ◽  
Harald Harris Hjelde ◽  
Guro Birgitte Stene ◽  
Tore Amundsen
Keyword(s):  
Side Effects ◽  
Performance Status ◽  
Stage Iv ◽  
Chemotherapy Administration ◽  
Patient Reported ◽  
Related Quality ◽  
Eortc Qlq C30 ◽  
Health Related ◽  
Grade 3 ◽  
Eortc Qlq

9562 Background: Physicians might overestimate benefits and underestimate toxicity of cancer therapy. Thus, patient reported HRQoL is an important part of evaluating treatment effect and assessing side effects. HRQoL is commonly reported once per chemotherapy cycle and just prior to administration of the next course (day 0). Several studies have not detected differences in HRQoL despite differences in physician-observed toxicity. We hypothesized that HRQoL varies during chemotherapy cycles; that side effects are most pronounced the first week after chemotherapy administration; and that repeated assessments improve the ability to detect differences in HRQoL. Methods: Patients were randomized to receive 3 courses of either vinorelbine/carboplatin (VC) or gemcitabine/carboplatin (GC) every 3 weeks. They reported HRQoL on the EORTC QLQ C30 + LC13 on day 0, 3, 8, 11, 15 and 22 of each cycle. A difference in mean scores of > 5 points is considered clinically detectable. Results: 52 pts (VC: 25, GC: 27); median age 65; 56 % men; 85 % stage IV; 93 % performance status 0-1; 75 % completed 3 cycles; 32 % response-rate; 71 % grade 3-4 toxicity. Baseline characteristics; treatment administered and outcomes of therapy were similar between treatment arms. Completion rates of QLQs were 96-64 %. There were significant variations in mean scores during cycles for several domains (mean scores during cycle 1 for some domains are listed in the table). For several domains, there were differences of > 5 points between the treatments arms at day 3-15 that were not detectable on day 22 (day 0 of next cycle). In general, treatment related symptoms were most pronounced on day 3 in every cycle. Conclusions: Our results suggest that timing and number of assessments influence the likelihood of detecting differences in HRQoL during chemotherapy. Day 3 was the best time point for assessing reduced function and side effects of the regimens administered in our trial. [Table: see text]

Quality of life (QoL) and therapy management in metastatic colorectal cancer (mCRC) patients treated with FOLFIRI and aflibercept in Germany, Switzerland, and Austria (GSA): Interim results of the noninterventional QoLiTrap-study.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 681-681 ◽  
Author(s):  
Ralf Hofheinz ◽  
Josef Thaler ◽  
Roger Von Moos
Keyword(s):  
Global Health ◽  
Interim Analysis ◽  
Progression Free Survival ◽  
Response To Treatment ◽  
Tumor Control ◽  
Cycle Number ◽  
First Results ◽  
Eortc Qlq C30 ◽  
Grade 3 ◽  
Eortc Qlq

681 Background: QoLiTrap (AIO-LQ-0113) is a non-interventional study to assess the QoL and clinical outcomes of mCRC patients treated with Aflibercept and Folfiri in Germany, Austria and Switzerland. This interim analysis shows the first results of the study. Methods: QoL is assessed by EORTC-QLQ C30 questionnaires that are filled in by the patients at baseline and before every therapy cycle. Clinical data (overall survival, progression-free survival (PFS), response to treatment, therapeutic sequences) are reported by participating physicians. Results: The first 277 patients who completed at least baseline and 2 additional EORTC questionnaires were included in this analysis. Median cycle number at the time of analysis was 6 (including patients still on therapy). Therapeutic sequences comprised treatment with Bevacizumab (B) (48%), anti-EGFR (13%), both (13%) or no biological (14%) before Aflibercept (A) (n.d.: 12%). Median PFS was similar in B (PFS: 6.6 months, CI[5.4;8.9]) and anti-EGFR (PFS: 7 months, CI[4.7,12.1]) pre-treated patients. Complete or partial remission was observed in 22%, Stable Disease in 52% and Progressive Disease in 26% of all patients with evaluated response (n=144). Main grade 3-5 adverse events were hypertension (15.9%) and diarrhea (6%). Only minor changes in EORTC global health score were observed from baseline (57.50; sd: 20.39; n=277) to cycle 6 (52.27; sd: 20.6; n=114). Conclusions: In clinical practice A is used in various therapeutic sequences in GSA. This interim analysis provides encouraging results with a tumor control rate of 74% in patients with response documentation and similar median PFS values for B and anti-EGFR pretreated patients. The decline in global health status was moderate. No unexpected safety signals were observed. This study is supported by Sanofi. Clinical trial information: AIO-LQ-0113.

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