scholarly journals CyberKnife for Recurrent Malignant Gliomas: A Systematic Review and Meta-Analysis

2021 ◽  
Vol 11 ◽  
Author(s):  
Lucio De Maria ◽  
Lodovico Terzi di Bergamo ◽  
Alfredo Conti ◽  
Kazuhiko Hayashi ◽  
Valentina Pinzi ◽  
...  
Keyword(s):  
Overall Survival ◽  
Median Time ◽  
Median Overall Survival ◽  
Meta Analysis ◽  
Malignant Gliomas ◽  
Progression Free Survival ◽  
Who Grade ◽  
Time To Recurrence ◽  
Who Grade Iii ◽  
Grade Iii

Background and ObjectivePossible treatment strategies for recurrent malignant gliomas include surgery, chemotherapy, radiotherapy, and combined treatments. Among different reirradiation modalities, the CyberKnife System has shown promising results. We conducted a systematic review of the literature and a meta-analysis to establish the efficacy and safety of CyberKnife treatment for recurrent malignant gliomas.MethodsWe searched PubMed, MEDLINE, and EMBASE from 2000 to 2021 for studies evaluating the safety and efficacy of CyberKnife treatment for recurrent WHO grade III and grade IV gliomas of the brain. Two independent reviewers selected studies and abstracted data. Missing information was requested from the authors via email correspondence. The primary outcomes were median Overall Survival, median Time To Progression, and median Progression-Free Survival. We performed subgroup analyses regarding WHO grade and chemotherapy. Besides, we analyzed the relationship between median Time To Recurrence and median Overall Survival from CyberKnife treatment. The secondary outcomes were complications, local response, and recurrence. Data were analyzed using random-effects meta-analysis.ResultsThirteen studies reporting on 398 patients were included. Median Overall Survival from initial diagnosis and CyberKnife treatment was 22.6 months and 8.6 months. Median Time To Progression and median Progression-Free Survival from CyberKnife treatment were 6.7 months and 7.1 months. Median Overall Survival from CyberKnife treatment was 8.4 months for WHO grade IV gliomas, compared to 11 months for WHO grade III gliomas. Median Overall Survival from CyberKnife treatment was 4.4 months for patients who underwent CyberKnife treatment alone, compared to 9.5 months for patients who underwent CyberKnife treatment plus chemotherapy. We did not observe a correlation between median Time To Recurrence and median Overall Survival from CyberKnife. Rates of acute neurological and acute non-neurological side effects were 3.6% and 13%. Rates of corticosteroid dependency and radiation necrosis were 18.8% and 4.3%.ConclusionsReirradiation of recurrent malignant gliomas with the CyberKnife System provides encouraging survival rates. There is a better survival trend for WHO grade III gliomas and for patients who undergo combined treatment with CyberKnife plus chemotherapy. Rates of complications are low. Larger prospective studies are warranted to provide more accurate results.

Long-Term Outcome of Postoperative Irradiation in Patients with Newly Diagnosed WHO Grade III Anaplastic Gliomas

2009 ◽  
Vol 95 (3) ◽  
pp. 317-324 ◽  
Author(s):  
Monika Nagy ◽  
Daniela Schulz-Ertner ◽  
Marc Bischof ◽  
Thomas Welzel ◽  
Holger Hof ◽  
...  
Keyword(s):  
Overall Survival ◽  
Median Overall Survival ◽  
Postoperative Radiotherapy ◽  
Progression Free Survival ◽  
Who Grade ◽  
Long Term Outcome ◽  
Free Survival ◽  
Anaplastic Gliomas ◽  
Who Grade Iii ◽  
Grade Iii

Purpose Patients with anaplastic gliomas have a more favorable overall survival than patients with glioblastomas. In most analyses, WHO grade III and IV tumors are not analyzed separately. The present analysis reports outcome after postoperative radiotherapy in patients with WHO grade III gliomas. Patients and methods Between January 1988 and January 2007, 127 patients with WHO grade III tumors were treated with radiotherapy; the histological classification was pure astrocytoma in 104 patients, oligoastrocytoma in 12 and pure oligodendroglioma in 11 patients. Median age was 48 years. After the primary diagnosis, a biopsy had been performed in 72 patients; subtotal and total resections were performed in 37 and 18 patients, respectively. In all patients radiotherapy was applied with a median dose of 60 Gy in conventional fractionation. The median follow-up time was 18 months. Results Median overall survival was 17 months. Overall survival was significantly influenced by the extent of surgery. Median overall survival was 32 months after complete resection, 36 months after subtotal resection, and 12 months after biopsy. Median overall survival was 7 months for patients with anaplastic astrocytomas, 44 months for patients with mixed tumors, and 47 months for those with pure oligodendrogliomas. Age significantly influenced overall survival. Median progression-free survival was 9 months; the extent of neurosurgical resection significantly influenced progression-free survival. Conclusion Patients with WHO grade III anaplastic astrocytomas, oligodendrogliomas and oligoastrocytomas show favorable overall survival after postoperative radiotherapy compared with glioblastoma patients and should therefore be analyzed separately. Radiochemotherapy might further improve outcome.

scholarly journals NCOG-48. TRANSFORMATION FROM LOW GRADE MENINGIOMA AND PROGNOSTIC FACTORS FOR SHORTER TIME TO RECURRENCE OF WHO GRADE III MENINGIOMA DIAGNOSIS

2020 ◽  
Vol 22 (Supplement_2) ◽  
pp. ii140-ii140
Author(s):  
Jessica Chew ◽  
William Chen ◽  
Matthew S Susko ◽  
Harish N Vasudevan ◽  
Steve Braunstein ◽  
...  
Keyword(s):  
Overall Survival ◽  
Survival Rates ◽  
Unmet Need ◽  
Low Grade ◽  
Who Grade ◽  
Subsequent Transformation ◽  
Time To Recurrence ◽  
Who Grade Iii ◽  
Grade Iii

Abstract BACKGROUND WHO grade III meningiomas are rare, and clinical outcomes data are limited. To address this problem, we analyzed a single institution retrospective cohort of patients with WHO grade III meningiomas. METHODS Patients who underwent resection of WHO grade III meningiomas between 1983 and 2019 with available follow-up data were included. Treatment, local recurrence, and overall survival rates were obtained. Kaplan-Meier analysis, log rank tests, and Student’s t tests were used for statistical analyses. RESULTS Ninety consecutive patients met inclusion criteria. Median follow-up was 3.2 years (IQR: 1.2-7.9), median age was 58 years (IQR: 46-67). Twenty-three patients (26%) underwent resection alone, and 58 (64%) underwent resection with adjuvant radiotherapy. Fifty-one patients developed local recurrences, with median time to recurrence of 1.0 year (IQR: 0.6-2.9) and higher MIB-1 labeling index for tumors that recurred within 1 year (25% versus 17%, p=0.04). There was a median of 2 recurrences per patient (IQR: 1-3), with a median of 2 resections and 2 radiotherapy courses for initial and salvage treatments. Thirty-nine patients with recurrences died, with median overall survival of 3.7 years (IQR: 1.8-8.8). Thirty-seven patients (41%) had prior low grade meningioma diagnoses with subsequent transformation to grade III, including 6 (7%) with grade I, 16 (18%) with grade II, and 15 (17%) with unknown grade. There was a median of 1 low grade recurrence per patient (IQR: 0-3) before transformation to grade III, which occurred a median of 4.3 years (IQR: 2.4-9.9) after initial diagnosis. Prior low grade diagnosis was associated with shorter time to recurrence of WHO grade III meningioma (p=0.01), and worse overall survival (p=0.03). CONCLUSION Patients with WHO grade III meningioma have poor outcomes despite aggressive multimodal therapy, and there is an urgent, unmet need for new high grade meningioma treatments.

scholarly journals A systematic review of treatment outcomes in pediatric patients with intracranial ependymomas

2013 ◽  
Vol 11 (6) ◽  
pp. 673-681 ◽  
Author(s):  
Tene A. Cage ◽  
Aaron J. Clark ◽  
Derick Aranda ◽  
Nalin Gupta ◽  
Peter P. Sun ◽  
...  
Keyword(s):  
Overall Survival ◽  
Pediatric Patients ◽  
Progression Free Survival ◽  
Tumor Location ◽  
Who Grade ◽  
Free Survival ◽  
Grade Ii ◽  
Infratentorial Tumors ◽  
Who Grade Iii ◽  
Grade Iii

Object Ependymoma is the third most common primary brain tumor in children. Tumors are classified according to the WHO pathological grading system. Prior studies have shown high levels of variability in patient outcomes within and across pathological grades. The authors reviewed the results from the published literature on intracranial ependymomas in children to describe clinical outcomes as they relate to treatment modality, associated mortality, and associated progression-free survival (PFS). Methods A search of English language peer-reviewed articles describing patients 18 years of age or younger with intracranial ependymomas yielded data on 182 patients. These patients had undergone treatment for ependymoma with 1 of 5 modalities: 1) gross-total resection (GTR), 2) GTR as well as external beam radiation therapy (EBRT), 3) subtotal resection (STR), 4) STR as well as EBRT, or 5) radiosurgery. Mortality and outcome data were analyzed for time to tumor progression in patients treated with 1 of these 5 treatment modalities. Results Of these 182 patients, 69% had supratentorial ependymomas and 31% presented with infratentorial lesions. Regardless of tumor location or pathological grade, STR was associated with the highest rates of mortality. In contrast, GTR was associated with the lowest rates of mortality, the best overall survival, and the longest PFS. Children with WHO Grade II ependymomas had lower mortality rates when treated more aggressively with GTR. However, patients with WHO Grade III tumors had slightly better survival outcomes after a less aggressive surgical debulking (STR+EBRT) when compared with GTR. Conclusions Mortality, PFS, and overall survival vary in pediatric patients with intracranial ependymomas. Pathological classification, tumor location, and method of treatment play a role in outcomes. In this study, GTR was associated with the best overall and PFS rates. Patients with WHO Grade II tumors had better overall survival after GTR+EBRT and better PFS after GTR alone. Patients with WHO Grade III tumors had better overall survival after STR+EBRT. Patients with infratentorial tumors had improved overall survival compared with those with supratentorial tumors. Progression-free survival was best in those patients with infratentorial tumors following STR+EBRT. Consideration of all of these factors is important when counseling families on treatment options.

scholarly journals Mitotic and Proliferative Indices in WHO Grade III Meningioma

Cancers ◽  
2020 ◽  
Vol 12 (11) ◽  
pp. 3351
Author(s):  
Andrea Daniela Maier ◽  
Christian Beltoft Brøchner ◽  
Jiri Bartek Jr. ◽  
Frank Eriksson ◽  
Heidi Ugleholdt ◽  
...  
Keyword(s):  
Mitotic Index ◽  
Hot Spot ◽  
Progression Free Survival ◽  
Ki 67 ◽  
Who Grade ◽  
Free Survival ◽  
Phosphohistone H3 ◽  
Proliferative Indices ◽  
Who Grade Iii ◽  
Grade Iii

Meningiomas with inherently high mitotic indices and poor prognosis, such as WHO grade III meningiomas, have not been investigated separately to establish interchangeability between conventional mitotic index counted on H&E stained slides (MI) and mitotic index counted on phosphohistone-H3 stained slides (PHH3 MI). This study investigates the agreement of MI and PHH3 MI and to analyze the association of progression-free survival (PFS) and MI, PHH3 MI, and the proliferative index (PI, Ki-67) in WHO grade III meningioma. Tumor specimens from 24 consecutive patients were analyzed for expression of Ki-67, PHH3 MI, and MI. Quantification was performed independently by two observers who made replicate counts in hot spots and overall tumor staining. Repeatability in replicate counts from MI and PHH3 MI was low in both observers. Consequently, we could not report the agreement. MI, PHH3 MI and hot spot counts of Ki-67 were associated with PFS (MI hot spot HR = 1.61, 95% CI 1.12–2.31, p = 0.010; PHH3 MI hot spot HR = 1.59, 95% CI 1.15–2.21, p = 0.006; Ki-67 hot spot HR = 1.06, 95% CI 1.02–1.11. p = 0.004). We found markedly low repeatability of manually counted MI and PHH3 MI in WHO grade III meningioma, and we could not conclude that the two methods agreed. Subsequently, quantification with better repeatability should be sought. All three biomarkers were associated with PFS.

PATH-32. EXTENT, PATTERN, AND PROGNOSTIC VALUE OF MGMT PROMOTOR METHYLATION: DOES IT DIFFER BETWEEN GLIOBLASTOMA AND IDH-WILDTYPE/TERT-MUTATED ASTROCYTOMA?

2021 ◽  
Vol 23 (Supplement_6) ◽  
pp. vi122-vi122
Author(s):  
Nico Teske ◽  
Philipp Karschnia ◽  
Jonathan Weller ◽  
Sebastian Siller ◽  
Mario M Dorostkar ◽  
...  
Keyword(s):  
Overall Survival ◽  
Sanger Sequencing ◽  
Favourable Outcome ◽  
Who Grade ◽  
Cpg Sites ◽  
Specific Pcr ◽  
Grade Ii ◽  
Radio Chemotherapy ◽  
Who Grade Iii ◽  
Grade Iii

Abstract INTRODUCTION The cIMPACT-NOW update 6 introduced glioblastoma diagnosis based on the combination of IDH-wildtype (IDHwt) status and TERT promotor mutation (pTERTmut). In glioblastoma as defined by histopathology according to the WHO 2016 classification, MGMT promotor status is associated with outcome. Whether this is also true in glioblastoma defined by molecular markers is yet unclear. METHODS We searched the institutional database for patients with: 1.) glioblastoma defined by histopathology; and 2.) IDHwt astrocytoma with pTERTmut. MGMT promotor methylation was analysed using methylation-specific PCR and Sanger sequencing of CpG sites within the MGMT promotor region. RESULTS We identified 224 patients with glioblastoma diagnosed based on histopathology, and 71 patients with IDHwt astrocytoma with pTERTmut (32 astrocytomas WHO grade II and 39 astrocytomas WHO grade III). There was no difference in the number of MGMT methylated tumors between the two groups as determined per PCR, and also neither the number nor the pattern of methylated CpG sites differed as determined per Sanger sequencing. Progression-free (PFS) and overall survival (OS) was similar between the two groups. Surgery was associated with improved overall survival in IDHwt astrocytoma with pTERTmut. In patients treated with radiochemotherapy or radiotherapy, higher numbers of methylated CpG sites were associated with favourable outcome in both groups. CONCLUSION Extent and pattern of methylated CpG sites are similar in glioblastoma and IDHwt astrocytoma with pTERTmut. In both groups, higher numbers of methylated CpG sites are associated with favourable outcome when radio/chemotherapy is administered. Surgery may form the basis for favourable outcome.

scholarly journals RADT-38. ADJUVANT RADIOTHERAPY FOR INTRACRANIAL ATYPICAL AND MALIGNANT MENINGIOMAS IN ADULT PATIENTS

2020 ◽  
Vol 22 (Supplement_2) ◽  
pp. ii189-ii190
Author(s):  
Ansley Unterberger ◽  
Aditya Kondajji ◽  
Daniel Kulinich ◽  
Courtney Duong ◽  
Isaac Yang
Keyword(s):  
Median Time ◽  
Primary Brain Tumor ◽  
Adjuvant Radiation ◽  
High Grade ◽  
Inclusion Criteria ◽  
Who Grade ◽  
Time To Recurrence ◽  
Grade Ii ◽  
Grade Iii

Abstract BACKGROUND Meningiomas, the most common primary brain tumor, account for more than one third of all primary CNS tumors. High-grade meningiomas, WHO grade II and III, comprise between 16%-24% of total meningiomas and are more aggressive, recur more frequently, and portend a worse prognosis than WHO grade I meningiomas. Adjuvant radiation of high-grade meningiomas, while not uncommon, remains variably described in current literature. To assess our institution’s radiation protocol, we examined our cohort of over 200 high-grade meningiomas. METHODS We queried our hospital’s EHR system for surgically resected meningiomas from January 2013 to December 2019. Of 286 results identified, 24 patients met the inclusion criteria: 1) histologically confirmed WHO grade II or III meningioma, 2) primary resection coupled with adjuvant radiation therapy, and 3) no chemotherapy. Only one WHO grade III meningioma met inclusion criteria. Patients with NF2 were excluded. Patient demographics, radiation dosage, fraction number, and dates of surgery, radiation onset, recurrence, and most recent follow-up were recorded. RESULTS Median age at surgery was 56.2 years (± 11.1, range 37.8 – 81.7), and males comprised 70.8% (n = 17) of the population. Only FSRT or IMRT were employed. The most frequent dosage was 55.8 Gy across 31 fractions with a median time to radiation of 2.7 months (± 3.0, range 1.0 – 12.6). 5 out of 24 patients experienced recurrence, which did not include the WHO III tumor. Median time to recurrence was 3.0 years (± 2.0, range .3 – 5.8). Median follow up was 3.5 years (± 2.2, range .3 – 9.3). CONCLUSIONS A fraction of our population experienced recurrence, regardless of grade II or grade III pathology. FSRT remains a safe and effective adjuvant therapy for high-grade meningioma after surgical resection. Future prospective studies comparing differing radiation modalities should be conducted.

Front-Line Treatment of Low-Grade Non-Follicular Non-Hodgkin Lymphoma (Final Report of Gisl LL02 Trial).

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 2332-2332
Author(s):  
Maria Goldaniga ◽  
Francesco Merli ◽  
Caterina Stelitano ◽  
Vincenzo Callea ◽  
Fiorella Ilariucci ◽  
...  
Keyword(s):  
Hodgkin Lymphoma ◽  
Objective Response ◽  
Progression Free Survival ◽  
Final Report ◽  
Low Grade ◽  
Who Grade ◽  
Free Survival ◽  
Non Hodgkin Lymphoma ◽  
Who Grade Iii ◽  
Grade Iii

Abstract Indolent Non-follicular non-Hodgkin Lymphoma (NFo-NHL) is a group of relatively frequent lymphoproliferative diseases, nevertheless extended clinical and prognostic studies are still lacking. In 2002 the Gruppo Italiano Studio Linfomi (GISL) initiated a LL02 prospective multicenter phase II trial, with the aim to evaluate the efficacy and safety of FC combination in the first-line therapy of NFo-NHL patients younger than 70 years. Between July 2002 and September 2006, 58 adult patients (35 males and 23 females, median age 64 yrs, range 40–75) affected by NFo-NHL in active disease phase, were consecutively enrolled in 12 GISL Hematological Centres. Patients were treated with a dose of 25 mg/mq Fludarabine plus 250 mg/mq Cyclophosphamide administred intravenously daily for 3 days; each cycle was repeated every 28 days for 6 courses. During the treatment patients received oral thrimethoprim-sulphametoxazole prophylaxis. After the intermediate evaluation, 48/58 patients (82.8%) had an objective response (ORR) with a 20.7% of complete remission (CR) plus 62.1% of partial remission (PR); at the final evaluation the ORR percentage was 84.5% with a 41.4% of CR (24 pts) and 43.1% of PR (25 pts); three patients were in progressive disease (5.2%) and one in stable disease (1.7%). The median overall survival (OS) was not reached with an 88% and 84% at 12 and 24 months; the progression free survival (PFS) was 89% and 77% and the event free survival (EFS) was 81% and 66% at 12 and 24 months respectively.About the toxicity profile, the major toxicity was hematological with a 18% cases of WHO grade III or IV anemia, 40% leucopenia, 33% neutropenia and 10% piastrinopenia. The 12% of patients had an infective episode wich a 7.7% of WHO grade III–IV.In conclusion the FC chemotherapy is a useful chance for advanced untreated non follicular low-grade NHL, with an optimal ORR, CR and PFS. The crucial point of FC remains OS, that not seems to be significantly improved in comparison with fludarabine alone or with standard therapy, even though the better quality of responses; Rituximab plus FC association is growing in literature as the probably key to find a real improvement also in this aspect.

The Newly Developed Modified BEACOPP-Regimen (BACOPP) Is Active and Feasible in Elderly Patients with Hodgkin Lymphoma: Results of a Phase II Study of the German Hodgkin Study Group (GHSG)

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 2600-2600
Author(s):  
Horst Mueller ◽  
Lucia Nogova ◽  
Dennis A Eichenauer ◽  
Teresa Halbsguth ◽  
Hiltrud Nisters-Backes ◽  
...  
Keyword(s):  
Overall Survival ◽  
Elderly Patients ◽  
Treatment Failure ◽  
Phase Ii Study ◽  
Final Analysis ◽  
Who Grade ◽  
Kaplan Meier ◽  
Advanced Stages ◽  
Who Grade Iii ◽  
Grade Iii

Abstract Background: Approximately 20% of patients diagnosed with Hodgkin lymphoma (HL) are more than 60 years of age. These elderly patients still have a poor prognosis, especially when presenting with advanced stages and higher age. The main reason is underdosing of treatment, which is due to reduced tolerability of chemotherapy and age-related comorbidities. In the GHSG experience, elderly patients in the HD9 trial did not profit from the BEACOPP regimen in terms of overall survival, though a better HL specific freedom from treatment failure was achieved as compared to COPP/ABVD. Thus, the GHSG has developed the BACOPP regimen (bleomycin, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone), in which etoposide was omitted to improve tolerability. Further modifications were a 1 week pretreatment phase with vincristine and prednisone, a limitation of vincristine in patients older than 65 years, an increase of the anthracyclines dose, and concomitant application of erythropoietin. Here we report on the final analysis of this multi-center phase II study for elderly patients. Methods: Between 2004 and 2005, 65 patients with HL in intermediate or advanced stages aged between 60 and 75 years were recruited. Treatment consisted of 6 cycles BACOPP in patients achieving a complete remission (CR) after 4 cycles or 8 cycles BACOPP in case of PR (partial remission) after 4 cycles. The primary endpoints were protocol adherence and response rates. Secondary endpoints included WHO grade III/IV toxicities, Kaplan Meier estimates of progression free survival (PFS), freedom from treatment failure (FFTF), and overall survival (OS). Results: Sixty patients (92%) were eligible for the final analysis. The majority of treatment courses (75%) were administered according to protocol. However, there was a tendency towards reduced dosing in cycles 5 to 8, especially for patients who had reached a CR after 4 cycles of BACOPP. In total, 51 patients showed CR/CRu (85%), 2 PR (3%) and 4 progression of disease (7%). Survival estimates and their 95% confidence intervals are shown in table 1. Table 1. Kaplan-Meier rates and 95% confidence intervals (CI) for FFTF, PFS and OS. time point rate (%) CI (95%) FFTF 12 months 73 61–84 24 months 67 55–79 PFS 12 months 75 64–86 24 months 68 56–80 OS 12 months 85 76–94 24 months 76 65–87 WHO grade III–IV toxicities were documented in 52 patients (87%). With a median observation time of 33 months, 18 deaths (30%) have been observed. Seven therapy associated fatal outcomes were documented. Conclusion: The new BACOPP regimen developed for elderly HL patients shows a high CR rate (85%). The FFTF rate at 2 years is within the range known from other schedules in this patient cohort. Overall, the regimen is feasible, but the therapy-associated death rate was high in our patient cohort. Thus, further studies and new approaches are still needed to substantially improve the outcome of elderly patients with early unfavorable or advanced stage HL.

Alternating versus continuous “FOLFIRI” in advanced colorectal cancer (ACC): A randomized “GISCAD” trial

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 3505-3505 ◽  
Author(s):  
R. Labianca ◽  
I. Floriani ◽  
E. Cortesi ◽  
L. Isa ◽  
A. Zaniboni ◽  
...  
Keyword(s):  
Overall Survival ◽  
Median Overall Survival ◽  
Experimental Studies ◽  
Progression Free Survival ◽  
Continuous Treatment ◽  
Who Grade ◽  
Free Survival ◽  
Alternating Chemotherapy ◽  
Grade 3

3505 Background: In ACC “FOLFIRI” is one of the standard regimens and is able to obtain about 40% response rate (RR) with an overall survival (OS) of 17–18 months. Experimental studies (Sobrero, 2000) indicate that an alternating chemotherapy could delay the appearance of cell resistance and reduce the therapeutic load for patients (pts). Methods: In order to evaluate whether intermittent “FOLFIRI” (CPT-11: 180 mg/sqm d1 + l-folinic acid -FA: 100 mg/sqm in 2 hr + 5fluorouracil-5FU: 400 mg/sqm bolus + 600 mg/sqm 22 hr infusion, d 1 and 2 every 2 weeks, for 2 months on and 2 months off) (arm A) was at least as effective as continuous “FOLFIRI” (same regimen, every month) (arm B), until progression in both arms, 336 pts from 27 Centers were randomised from 7/2001 to 6/2005. The characteristics of pts were: median age 64 years (r 29–75), males 214 (63%), PS 0: 222 (66%), liver mets only 166 (49%), multiple mts including liver 80 (24%). Results: RR was 29% in arm A and 35% in arm B, with a median progression-free survival (PFS) of 8.8 and 7.3 months respectively (HR = 1.00, 95% CI: 0.74 - 1.36). At a median follow-up of 27 months, median overall survival (OS), the primary endpoint of the trial, was 16.9 months in arm A and 17.6 in arm B (HR = 1.11, 95% CI: 0.83 - 1.48). Toxicity was acceptable and similar in the 2 arms (WHO grade 3–4 toxicity: neutropenia in 12% pts, diarrhoea in 11%, nausea/vomiting in 4% and fatigue in 3%). Conclusions: Our results demonstrate that alternating “FOLFIRI” obtains the same survival as a continuous treatment, thus reducing the discomfort to pts and the economic costs. No significant financial relationships to disclose.

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