First-line chemotherapy with cisplatin plus fractionated temozolomide in recurrent glioblastoma multiforme: a phase II study of the Gruppo Italiano Cooperativo di Neuro-Oncologia.

PURPOSE: Cisplatin and temozolomide (TMZ) are active in glioblastoma multiforme (GBM), with different profiles of toxicity. A bid regimen of TMZ achieves a strong inhibition of O(6)-alkylguanine DNA-alkyl transferase (AGAT), and cisplatin reduces AGAT activity in vitro, suggesting a possible synergic interaction. The primary end point of the present multicenter phase II study was progression-free survival (PFS) at 6 months (PFS-6); secondary end points included response, toxicity, and overall survival. PATIENTS AND METHODS: Chemotherapy-naive patients with GBM who experienced disease recurrence or progression after surgery and standard radiotherapy were eligible. Chemotherapy cycles consisted of cisplatin 75 mg/m(2) on day 1, TMZ 130 mg/m(2) bolus followed by nine doses of 70 mg/m(2) every 12 hours (total of 5 days) from day 2 every 4 weeks. In the absence of hematologic toxicity, TMZ was escalated to 1,000 mg/m(2) in 5 days. RESULTS: A total of 50 patients (median age, 53.4 years; range, 27 to 70 years; median Karnofsky performance status, 80; range, 60 to 100) were accrued in the study. PFS-6 was 34% (95% CI, 23% to 50%), and PFS-12 was 4% (95% CI, 0.3% to 16%). Median PFS was 18.4 weeks (95% CI, 13 to 25.9 weeks). Among 49 assessable patients, one complete response and nine partial responses were obtained, with an overall response rate of 20.4% (95% CI, 7.7% to 33%). Among 203 treatment cycles delivered, the most common grade 3 or grade 4 events included granulocytopenia in 7.9% of cycles, thrombocytopenia in 4%, and neurologic toxicity in three patients (6%). CONCLUSION: The new cisplatin plus bid TMZ regimen appears active in chemotherapy-naive patients with recurrent GBM and incurs an acceptable toxicity.     

Second-line chemotherapy with irinotecan plus carmustine in glioblastoma recurrent or progressive after first-line temozolomide chemotherapy: a phase II study of the Gruppo Italiano Cooperativo di Neuro-Oncologia (GICNO).

PURPOSE: Glioblastoma multiforme (GBM), the most frequent brain tumor in adults, is not considered chemosensitive. Nevertheless, there is widespread use of first-line chemotherapy, often with temozolomide, as a therapeutic option in patients with progressive disease after surgery and radiotherapy. However, at the time of second recurrence and/or progression, active and noncross-resistant chemotherapy regimens are required. The aim of the present multicenter phase II trial, therefore, was to ascertain the efficacy of second-line carmustine (BCNU) and irinotecan chemotherapy. PATIENTS AND METHODS: Patients with histologically confirmed GBM, recurring or progressing after surgery, standard radiotherapy and a first-line temozolomide-based chemotherapy, were considered eligible. The primary end-point was progression-free survival at 6 months (PFS-6), and secondary end-points included response rate, toxicity, and survival. All patients were on enzyme-inducing antiepileptic prophylaxis. Chemotherapy consisted of BCNU (100 mg/m2 on day 1) plus irinotecan (175 mg/m2/weekly for 4 weeks), every 6 weeks, for a maximum of eight cycles. In the absence of grade 2 toxicity, the irinotecan dose was increased to 200 mg/m2. RESULTS: A total of 42 patients (median age, 53.4 years; median Karnofsky performance status, 80; range, 60 to 90) were included in the study. PFS-6 was 30.3% (95% CI, 18.5% to 49.7%). Median time to progression was 17 weeks (95% CI, 11.9 to 23.9). Nine partial responses (21.4%; 95% CI, 9% to 34%) were obtained. Toxicity was manageable. CONCLUSION: The BCNU plus irinotecan regimen seems active and non-cross-resistant in patients with GBM with recurrence after temozolomide-based chemotherapy.     

Gefitinib in patients with progressive high-grade gliomas: a multicentre phase II study by Gruppo Italiano Cooperativo di Neuro-Oncologia (GICNO)

To investigate the role of gefitinib in patients with high-grade gliomas (HGGs), a phase II trial (1839IL/0116) was conducted in patients with disease recurrence following surgery plus radiotherapy and first-line chemotherapy. Adult patients with histologically confirmed recurrent HGGs following surgery, radiotherapy and first-line chemotherapy, were considered eligible. Patients were treated with gefitinib (250 mg day(-1)) continuously until disease progression. The primary end point was progression-free survival at 6 months progression-free survival at 6 months (PFS-6). Tissue biomarkers (epidermal growth factor receptor (EGFR) gene status and expression, phosphorylated Akt (p-Akt) expression) were assessed. Twenty-eight patients (median age, 55 years; median ECOG performance status, 1) were enrolled; all were evaluable for drug activity and safety. Sixteen patients had glioblastoma, three patients had anaplastic oligodendrogliomas and nine patients had anaplastic astrocytoma. Five patients (17.9%, 95% CI 6.1-36.9%) showed disease stabilisation. The overall median time to progression was 8.4 (range 2-104+) weeks and PFS-6 was 14.3% (95% CI 4.0-32.7%). The median overall survival was 24.6 weeks (range 4-104+). No grade 3-4 gefitinib-related toxicity was found. Gefitinib showed limited activity in patients affected by HGGs. Epidermal growth factor receptor expression or gene status, and p-Akt expression do not seem to predict activity of this drug.     

Fotemustine as second-line treatment for recurrent or progressive glioblastoma after concomitant and/or adjuvant temozolomide: a phase II trial of Gruppo Italiano Cooperativo di Neuro-Oncologia (GICNO)

Background  Standardized salvage treatment has not yet proved effective in glioblastoma multiforme (GBM) patients who receive prior standard radiotherapy plus concomitant and adjuvant temozolomide. Methods  Patients with progressive GBM after radiotherapy plus concomitant and/or adjuvant temozolomide received three-weekly doses (100–75 mg m²) of fotemustine followed, after a 5-week rest, by fotemustine (100 mg m²) every 3 weeks for ≤1 year. Results  Forty-three patients (29 M, 14 F; median age 51 years, range 34–68; median KPS 90) were enrolled. Progression-free survival at 6 months (PFS-6) was 20.9% (95% CI: 9–33%); three patients (7.1%) had partial response (PR); 15 (34.9%), disease stabilization (SD). The median survival was 6 months (95% CI: 5–7). MGMT promoter status was methylated in 8 (18.6%) and unmethylated in 26 (60.5%) and not assessable in 9 (20.9%) patients, respectively. Disease control was 75% versus 34.6% in methylated and unmethylated MGMT patients (P = 0.044); no significant difference was found between groups for PFS-6 and survival. Grade 3 and 4 thrombocytopenia and neutropenia were observed in 20.9 and 16.3% of patients, during the induction phase, and in 0 and 9.5% patients during the maintenance phase, respectively. Conclusions  The findings of the present trial, that evaluate fotemustine in a homogeneous population, may represent a new benchmark for nitrosourea activity. Moreover, this is the first study to evaluate correlation between MGMT promoter status and outcome of fotemustine for relapsing GBM previously treated with radiotherapy and temozolomide.     

A multicenter study of the prognosis and treatment of adult brain ependymal tumors

BACKGROUND: The current analysis of outcomes in a large series of adult patients with intracranial ependymal tumors contributes to the characterization of the primary prognostic factors and to the therapeutic management of this rare disease, for which limited information is available in the literature. METHODS: The authors analyzed data on patient and tumor characteristics, treatment, and survival in a series of 70 patients age > 17 years with pathologic diagnoses of brain ependymal tumors from 4 institutions. RESULTS: The 5- and 10-year overall survival (OS) rates (+/- standard errors) were 67% +/- 6% and 50% +/- 8%, respectively. The 5- and 10-year failure-free survival (FFS) rates were 43% +/- 7% and 24% +/- 6%, respectively. Younger age and infratentorial tumor location were associated with longer survival. Among patients with Grade 2 ependymoma (n = 51), 21 (41%) received no postsurgical treatment. These 21 patients had a 5-year OS rate of 78% +/- 10% and a 10-year OS rate of 68% +/- 13%; the 5- and 10-year FFS rates for these patients were 47% +/- 12% and 12% +/- 11%, respectively. Twenty-six patients with Grade 2 ependymoma (51%) received postoperative radiotherapy (RT). These 26 patients had a 5-year OS rate of 71% +/- 9% and a 10-year OS rate of 59% +/- 11%; the 5- and 10-year FFS rates for these patients were 54% +/- 10% and 34% +/- 10%, respectively. Among patients with Grade 2 ependymoma, neither OS nor FFS differed significantly between those who did not receive postoperative RT and those who did; however, these two groups were heterogeneous with respect to prognostic factors. On multivariate analysis, RT use exhibited a trend toward improved OS and was significantly predictive of improved FFS. CONCLUSIONS: The current analysis does not rule out the possibility that deferral of RT at the time of recurrence could have a detrimental effect on FFS or OS in patients with Grade 2 ependymoma, regardless of the degree of ablation. The role of postoperative RT for patients who undergo imaging-based macroscopic total resection remains to be addressed.     

Weekly paclitaxel as first-line chemotherapy in elderly advanced breast cancer patients: a phase II study of the Gruppo Italiano di Oncologia Geriatrica (GIOGer).

BACKGROUND: First-line chemotherapy regimens suitable for elderly advanced breast cancer patients are still not defined. PATIENTS AND METHODS: Women with stage III or IV breast cancer aged > or =70 years were enrolled in a phase II study aimed to evaluate both activity and toxicity of weekly paclitaxel. Among 46 planned patients, at least 18 responses and not more than seven unacceptable toxic events are required for a favourable conclusion. Paclitaxel 80 mg/m(2) was administered weekly for 3 weeks every 28 days. RESULTS: Unacceptable toxicity occurred in seven out of 46 patients evaluated for toxicity [15.2%; exact 95% confidence interval (CI) 7.6% to 28.2%] and was represented by one case of febrile neutropenia, one case of severe allergic reaction and five cases of cardiac toxicity. Among 41 patients evaluated for response, a complete response occurred in two (4.9%) patients and a partial response in 20 (48.8%), with an overall response rate of 53.7% (exact 95% CI 38.7% to 67.9%). The median progression-free survival was 9.7 months (95% CI 8.5-18.7) and median survival was 35.8 months (95% CI 19-not defined). CONCLUSIONS: Weekly paclitaxel is highly active in elderly advanced breast cancer patients. Data on cardiovascular complications, however, indicate the need for a careful monitoring of cardiac function before and during chemotherapy.     

Phase II study of metronomic chemotherapy for recurrent malignant gliomas in adults

Preclinical evidence suggests that continuous low-dose daily (metronomic) chemotherapy may inhibit tumor endothelial cell proliferation (angiogenesis) and prevent tumor growth. This phase II study evaluated the feasibility of this antiangiogenic chemotherapy regimen in adults with recurrent malignant gliomas. The regimen consisted of low-dose etoposide (35 mg/m2 [maximum, 100 mg/day] daily for 21 days), alternating every 21 days with cyclophosphamide (2 mg/kg [maximum, 100 mg/day] daily for 21 days), in combination with daily thalidomide and celecoxib, in adult patients with recurrent malignant gliomas. Serum and urine samples were collected for measurement of angiogenic peptides. Forty-eight patients were enrolled (15 female, 33 male). Twenty-eight patients had glioblastoma multiforme (GBMs), and 20 had anaplastic gliomas (AGs). Median age was 53 years (range, 33-74 years), and median KPS was 70 (range, 60-100). Therapy was reasonably well tolerated in this heavily pretreated population. Two percent of patients had partial response, 9% had a minor response, 59% had stable disease, and 30% had progressive disease. For GBM patients, median progression-free survival (PFS) was 11 weeks, six-month PFS (6M-PFS) was 9%, and median overall survival (OS) was 21 weeks. For AG patients, median PFS was 14 weeks, 6M-PFS was 26%, and median OS was 41.5 weeks. In a limited subset of patients, serum and urine angiogenic peptides did not correlate with response or survival (p > 0.05). Although there were some responders, this four-drug, oral metronomic regimen did not significantly improve OS in this heavily pretreated group of patients who were generally not eligible for conventional protocols. While metronomic chemotherapy may not be useful in patients with advanced disease, further studies using metronomic chemotherapy combined with more potent antiangiogenic agents in patients with less advanced disease may be warranted.     

Results of a multicenter retrospective study on pediatric brain tumors in Italy

This retrospective study was undertaken to evaluate the clinical characteristics, course and treatment of children (0-14 years of age) diagnosed with a primary CNS tumor during the period 1976-1982 in Italy. Four hundred and sixty-two patients (263 males and 199 females) were followed by 18 various neurosurgical and pediatric oncology centers. The histologic types most frequently reported were: medulloblastoma (23%), astrocytoma (16%), ependymoma (11%) and spongioblastoma (11%). Of the 388 patients who underwent surgery, radical excision was reported in 42%, partial excision in 32%, biopsy only in 6%, and unqualified surgery in 4%; 19% had no surgery. Radiotherapy and chemotherapy combined were administered in 61% of the 143 patients followed at pediatric oncology centers; 19% received radiotherapy alone, 3% chemotherapy alone, and 17% neither treatment. Forty-six percent of the patients were reported alive, 40% dead, and 14% lost to follow-up. Performance status was identified for 62 patients. The investigation revealed marked differences in the therapeutic treatment administered, thus precluding valid data analysis. This emphasizes the need to coordinate efforts among the institutions and the disciplines involved in the treatment of this form of childhood cancer.     

Temozolomide as salvage treatment for recurrent intracranial ependymomas of the adult: a retrospective study

Background

Few data are available on temozolomide (TMZ) in ependymomas.We investigated the response, survival, and correlation with MGMT promoter methylation in a cohort of patients with adult intracranial ependymoma receiving TMZ as salvage therapy after failure of surgery and radiotherapy.

Patients and Methods

We retrieved clinical information from the institutional database and follow-up visits, and response to TMZ on MRI was evaluated according to the MacDonald criteria.

Results

Eighteen patients (median age, 42 y), with either WHO grade III (10) or grade II (8) ependymoma were evaluable. Tumor location at diagnosis was supratentorial in 11 patients and infratentorial in 7. Progression before TMZ was local in 11 patients, local and spinal in 6 patients, and spinal only in one patient. A median of 8 cycles of TMZ (1–24) was administered. Response to TMZ consisted of complete response (CR) in one (5%) patient, partial response (PR) in 3 (17%) patients, stable disease (SD) in 7 (39%) patients, and progressive disease (PD) in 7 (39%) patients. Maximum response occurred after 3, 10, 14, and 15 cycles, respectively, with neurological improvement in 2 patients. All 4 responding patients were chemotherapy naïve. Both anaplastic (2) and grade II (2) tumors responded. Median progression-free survival and overall survival were 9.69 months (95% CI, 3.22–30.98) and 30.55 months (95% CI, 12.85–52.17), respectively. MGMT methylation was available in 11 patients and was not correlated with response or outcome.

Conclusion

TMZ has a role in recurrent chemo-naïve adult patients with intracranial ependymoma, regardless of tumor grade and MGMT methylation. We suggest that, after failure of surgery and radiotherapy, TMZ should be considered as a possible first-line treatment for recurrent ependymoma.     

Chemotherapy for germ cell tumors relapsing after high-dose chemotherapy and stem cell support: A retrospective multicenter study of the Austrian Study Group on Urologic Oncology

Background: In most patients with advanced refractory germ cell tumorsundergoing high-dose chemotherapy with stem cell support (HDCT) the diseaseprogresses after HDCT. This study was designed to shed light on theunestablished role of post-HDCT chemotherapy.Patients and methods: In a retrospective multicenter study data of 47evaluable patients from nine centers subjected to post-HDCT chemotherapy forprogression of their germ cell tumors were collected in a questionnairesurvey and analyzed for treatment response and survival.Results: Of 191 patients pretreated by HDCT, 48 (25%) weresubjected to post-HDCT chemotherapy for disease progression. Remission wasachieved in 17 (36%) and marker-negative remission in eight(17%). The median survival time was 26 weeks, 65 weeks for respondersand 13 weeks for non-responders. Only one of 47 evaluable patients achievedsustained complete remission. Remissions significantly correlated with thepost-HDCT interval, the use of ifosfamide and the combination regimens ofcisplatin + etoposide i.v. or ifosfamide and of paclitaxel + ifosfamide orcisplatin. On univariate analysis a longer post-HDCT interval, the use ofcisplatin, paclitaxel and ifosfamide and the combined use of paclitaxel +ifosfamide and/or cisplatin significantly improved the chances of survival.On multivariate analysis only treatment with paclitaxel and ifosfamideretained independent prognostic significance for survival.Conclusions: One third of the patients considered to be candidates forfurther chemotherapy once progressive after HDCT went into remission with again in survival time. Sustained remissions may occur, but are rarely seen.Paclitaxel and ifosfamide appear to be the most effective drugs in theseheavily pretreated patients.     

Treatment patterns in elderly patients (greater than or equal to 70 years) with breast carcinoma. A retrospective study of the Gruppo Oncologico Clinico Cooperativo del nord-Est (GOCCNE)

The pattern of treatment used in elderly women affected by breast carcinoma was evaluated in a retrospective study by the North-East Clinical Cooperative Group in Italy (GOCCNE). Six divisions were involved in the study. The medical records of 115 elderly women were reviewed; the women's median age was 75 years (range, 70-93). Surgery was used in 70/72 operable patients (97%), although limited surgery plus radiotherapy was used in only 7.5%. Most stage II patients were treated with adjuvant tamoxifen, as were younger postmenopausal patients, according to the guidelines of the Bethesda Consensus Meeting. Comorbid conditions are of particular concern in therapy planning, considering that more stage III patients died of competing causes than for disease progression. The role of chemotherapy was very marginal.     

A trial of outpatient chemotherapy for recurrent head and neck tumors

A four-drug combination chemotherapy (bleomycin-methotrexate-vinblastine-CCNU) had been used in 38 evaluable patients with recurrent squamous cell carcinoma of the head and neck region on an outpatient basis. A large number of these patients had carcinoma of the oral cavity (45% of total). Nineteen patients (50%) responded to this regimen with a greater than or equal to 50% regression of their measured tumors. The median survival of all patients was 34 weeks. There was one chemotherapy-related death and the overall toxicity was mild. This convenient regimen can be considered a useful alternative to more aggressive therapy.     

The role of anthracyclines in combination chemotherapy for the treatment of follicular lymphoma: retrospective study of the Intergruppo Italiano Linfomi on 761 cases

In order to elucidate the role of anthracycline based combination chemotherapy regimens for the treatment of follicular lymphoma we conducted a retrospective study on a large series of patients with a histologically confirmed diagnosis of follicular lymphoma. The Italian lymphoma intergroup (ILI) promoted a retrospective study of patients with follicular lymphoma treated in cooperative trials between 1985 and 1996. Six hundred and thirty three cases were treated with an anthracycline-containing regimen and 128 patients were treated without anthracyclines. The two groups were prognostically comparable; in particular, no difference was observed according to both IPI and ILI prognostic index. Results showed a complete remission (CR) rate for patients treated with anthracyclines was 69.2% and overall response rate was 92.5%. After a median follow-up of 51 months (54 months for patients still alive), the 5- and 10-year overall survival (OS) rates were 80 and 66%, respectively. Disease-free survival (DFS) and failure-free survival (FFS) rates at 5 years were 61 and 49%, respectively. In the group of patients treated with combination chemotherapy not including anthracyclines, the CR rate was 67.5% and the overall response rate was 85.4%. A longer OS (80% at 5 years) was observed in patients treated with anthracyclines compared to 67% OS rate in patients treated without anthracyclines (p = 0.0004). FFS was significantly longer in patients treated with anthracyclines (49 vs. 34% p = 0.006). Patients treated with anthracyclines with low or intermediate risk according to ILI prognostic index showed a significantly longer OS (p = 0.0001 andp = 0.0009, respectively); those in the high-risk group showed a trend for a longer survival. In conclusion, this retrospective study shows that patients with follicular lymphoma treated with an anthracycline containing regimen had a better outcome compared to patients treated with other combination regimens non including anthracyclines in terms of CRs, OS and FFS. On the basis of these results anthracycline-containing regimens (ACR) should be considered as the standard treatment of patients with advanced follicular lymphoma.     

Clinicopathologic characteristics of granulosa cell tumors of the ovary: a multicenter retrospective study

Objective

To evaluate the clinicopathologic characteristics and prognostic factors of ovarian granulosa cell tumors.

Methods

Medical records of 113 patients presenting between January 1995 and December 2007 were retrospectively reviewed.

Results

One-hundred two patients had adult type disease, with a mean age of 46.2 years (range, 18 to 83 years) and a mean follow-up period of 54.7 months (range, 1 to 155 months). The distribution of FIGO stages was 86 patients at stage I, 11 at stage II, and 5 at stage III. During follow-up, ten patients recurred at a mean time of 48 months (range, 4 to 109 months). Among them, three patients died after a mean of 57 months (range, 25 to 103 months). In recurrence analysis, advanced stage (p=0.032) and presence of residual disease (p=0.012) were statistically significant, and age<40 years, premenopause and positive washing cytology were marginally significant (p<0.1). In multivariate analysis, stage was the only factor associated with recurrence; adjuvant chemotherapy and fertility-sparing surgery were not statistically significant. Among 36 patients with fertility-sparing operations, eight patients had nine pregnancies and delivered seven babies. Eleven patients had juvenile type tumors; the mean age was 20.0 years (range, 8 to 45 years) and the mean follow-up period was 69.8 months (range, 20 to 156 months). The distribution of FIGO stage was nine patients at stage I and two at stage III. There were no recurrences or deaths reported. Four patients had seven pregnancies and delivered six babies.

Conclusion

Stage is the only factor associated with disease-free survival, and fertility-sparing surgery may be a treatment option for women with early-stage disease who want to retain fertility.     

Prolonged survival in poor-risk diffuse large B-cell lymphoma following front-line treatment with rituximab-supplemented, early-intensified chemotherapy with multiple autologous hematopoietic stem cell support: a multicenter study by GITIL (Gruppo Italiano Terapie Innovative nei Linfomi).

A prospective multicenter program was performed to evaluate the combination of rituximab and high-dose (hd) sequential chemotherapy delivered with multiple autologous peripheral blood progenitor cell (PBPC) support (R-HDS-maps regimen) in previously untreated patients with diffuse large B-cell lymphoma (DLB-CL) and age-adjusted International Prognostic Score (aaIPI) score 2-3. R-HDS-maps includes: (i) three APO courses; (ii) sequential administration of hd-cyclophosphamide (CY), hd-Ara-C, both supplemented with rituximab, hd-etoposide/cisplatin, PBPC harvests, following hd-CY and hd-Ara-C; (iii) hd-mitoxantrone (hd-Mito)/L-Pam + 2 further rituximab doses; (iv) involved-field radiotherapy. PBPC rescue was scheduled following Ara-C, etoposide/cisplatin and Mito/L-Pam. Between 1999 and 2004, 112 consecutive patients aged <65 years (74 score 2, 38 score 3) entered the study protocol. There were five early and two late toxic deaths. Overall 90 patients (80%) reached clinical remission (CR); at a median 48 months follow-up, 87 (78%) patients are alive, 82 (73%) in continuous CR, with 4 year overall survival (OS) and event-free survival (EFS) projections of 76% (CI 68-85%) and 73% (CI 64-81%), respectively. There were no significant differences in OS and EFS between subgroups with Germinal-Center and Activated B-cell phenotype. Thus, life expectancy of younger patients with aaIPI 2-3 DLB-CL is improved with the early administration of rituximab-supplemented intensive chemotherapy compared with the poor outcome following conventional chemotherapy.     

A multicenter retrospective study of endoscopic resection for early gastric cancer

Background The reported outcomes of endoscopic resection (ER) for early gastric cancer (EGC) remain limited to several single-institution studies. Methods A multicenter retrospective study was conducted at 11 Japanese institutions concerning their results for ER, including conventional endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD). Results A total of 714 EGCs (EMR, 411; ESD, 303) in 655 consecutive patients were treated from January to December 2001. Technically, 511 of the 714 (71.6%) lesions were resected in one piece. The rate of one-piece resection with ESD (92.7%; 281/303) was significantly higher compared with that for EMR (56.0%; 230/411). Histologically, curative resection was found in 474 (66.3%) lesions. The rate of curative resection with ESD (73.6%; 223/303) was significantly higher compared with that for EMR (61.1%; 251/411). Blood transfusion because of bleeding was required in only 1 patient (0.1%) with EMR of 714 lesions. Perforation was found in 16 (2.2%). The incidence of perforation with ESD (3.6%; 11/303) was significantly higher than that with EMR (1.2%; 5/411). All complications were managed endoscopically, and there was no procedure-related mortality. The median follow-up period was 3.2 years (range, 0.5–5.0 years). In total, the 3-year cumulative residual-free/recurrence-free rate and the 3-year overall survival rate were 94.4% and 99.2%, respectively. The 3-year cumulative residual-free/recurrence-free rate in the ESD group (97.6%) was significantly higher than that in the EMR group (92.5%). Conclusion ER leads to an excellent 3-year survival in clinical practice and could be a possible standard treatment for EGC. ESD has the advantage of achieving one-piece resection and reducing local residual or recurrent tumor.     

Efficacy of adjuvant chemotherapy after curative resection for gastric cancer: A meta-analysis of published randomised trials: A study of the GISCAD (Gruppo Italiano per lo Studio dei Carcinomi dell'Apparato Digerente)

Background: Several studies have investigated the possible roleof the adjuvant chemotherapy after curative resection for gastriccancer failing to show a clear indication; previous meta-analysessuggested small survival benefit of adjuvant chemotherapy, butthe statistical methods used were open to criticisms. Materials and methods: Randomised trials were identified bymeans of Medline and CancerLit and by selecting references fromrelevant articles. Systematic review of all randomised clinicaltrials of adjuvant chemotherapy for gastric cancer comparedwith surgery alone, published before January 2000, were considered.Pooling of data was performed using the fixed effect model.Death for any cause was the study endpoint. The hazard ratioand its 95% confidence intervals (95% CI), derived accordingto the method of Parmar, were the statistics chosen for summarisingthe relative benefit of chemotherapy versus control. Results: Overall 20 articles (21 comparisons) were consideredfor analysis. Three studies used single agent chemotherapy,seven combination of 5-fluorouracil (5-FU) with anthracyclin,ten combination of 5-FU without anthracyclines. Informationon 3658 patients, 2180 deaths, was collected. Chemotherapy reduced the risk of death by 18% (hazard ratio0.82, 95% CI: 0.75–0.89, P < 0.001). Association ofAnthracyclines to 5-FU did not show a statistically significantimprovement when compared with the effect of the other regimens. Conclusions: Chemotherapy produces a small survival benefitin patients with curatively resected gastric cancer. However,taking into account the limitations of literature based meta-analyses,adjuvant chemotherapy is still to be considered as an investigationalapproach. adjuvant, chemotherapy, gastric cancer, meta-analysis, randomised clinical trial     

The value of a new diagnostic strategy for adipocytic soft tissue tumors in adults: A retrospective study

IntroductionThe distinction between lipoma and well-differentiated liposarcoma (WDLPS), or “atypical lipomatous tumor” (ALT), is crucial as it impacts patient management. A group of European experts led by Benjamin Moulin recently issued a consensus report to define the role of radiology in managing these lesions. It describes an algorithm defining the criteria prompting a diagnostic biopsy of deep lipomatous tumors of the limbs and chest wall. The primary aim of this study was to evaluate the algorithm's diagnostic performance.Materials and methodsBetween 2012 and 2019, all biopsies of deep fatty tumors of the limbs or chest wall with a pre-biopsy MRI assessment were recorded at our institution. The MRI scans were reviewed by two radiologists. Each lesion was classified according to biopsy status by applying the algorithm of the European panel. The algorithm's diagnostic performance was assessed by calculating the sensitivity, specificity, positive predictive value and negative predictive value. Inter-rater agreement was also assessed.ResultsOf the 156 tumors in our study, 148 (94.9%) required a biopsy, and the algorithm's sensitivity for detecting ALT/WDLPS was 100% with specificity of 6.3% and a PPV of 20.3%. Inter-rater agreement was almost perfect with a kappa value of 0.882.ConclusionThe European algorithm demonstrates perfect sensitivity, an important criterion for a screening examination such as MRI in this setting. The algorithm's low specificity, however, emphasizes the need for further studies to redefine the optimum size cut-off value, especially for lesions without atypical criteria or an anatomical location at risk of post-surgical recurrence.