Impact of age on the Quadrella index assessing oncological and functional results after prostate brachytherapy: A 6-year analysis.

Purpose: As the oncological results of prostate brachytherapy (BT) are excellent for low-risk (LR) or favorable intermediate-risk (FIR) prostate cancer (PCa), evaluating the side effects has become a major issue, especially for young men. The objective of the study was to compare the oncologic and functional results of BT using Quadrella index for patients aged 60 or less compared with older patients. Material and methods: From June, 2007 to June, 2017, 222 patients, including 70 ≤ 60 years old and 152 > 60 years old, underwent BT for LR-FIR PCa, with good erectile function at baseline according to International Index of Erectile Function-5 (IIEF-5) > 16. Quadrella index was achieved under the following circumstances: 1) Absence of biological recurrence (Phoenix criteria); 2) Absence of erectile dysfunction (ED) (IIEF-5 > 16); 3) No urinary toxicity (international prostate score symptom) IPSS < 15 or IPSS > 15, and ΔIPSS < 5; 4) No rectal toxicity (RT) (Radiation Therapy Oncology Group, RTOG = 0). Patients were treated on demand with phosphodiesterase inhibitors (PDE5i) post-operatively. Results: The Quadrella index was satisfied for about 40-80% of patients ≤ 60 years vs. 33-46% for older patients during 6-year follow-up (significant difference from the second year). At year 5, 100% of evaluable patients aged ≤ 60 and 91.8% > 60 (p = 0.29) reached Phoenix criteria. The criterion of ED (IIEF-5 < 16) largely explained the validity rate of Quadrella alone. There was no ED for 67.2-81.4% of patients ≤ 60 years compared with 40.0-56.1% for patients > 60 (significant difference since year 4 in favor of young men). After two years of follow-up, more than 90% of patients in both the groups showed neither urinary nor rectal toxicities. Conclusions: For young men displaying LR-FIR PCa, BT appears to be a first-class therapeutic option, as the oncological results were at least equivalent to those of older patients with good long-term tolerance.

Minimal channel GreenLight photovaporization before permanent implant prostate brachytherapy for patients with obstructive symptoms: Technically feasible and safe.

PURPOSE: Brachytherapy (BrT) is a standard treatment for low-risk to favorable-intermediate-risk prostate cancer but is a relative contraindication for patients with obstructive symptoms. We aimed to assess the feasibility and urinary toxicity of a minimal photovaporization (mPVP) before implantation. MATERIALS AND METHODS: Between 04/2009 and 08/2016, 50 patients candidates for BrT but with International Prostate Symptom Score (IPSS)>15, uroflowmetry <15 mL/s, obstructive prostate or large median lobe underwent a mPVP (GreenLight Laser) at least 6 weeks (median 8.5) before permanent seed implantation (loose seeds, 125I, 160 Gy). RESULTS: Two patients (4%) did not have sufficient improvement and did not undergo BrT, although it would have been possible at 3 months. For the 48 (96%) other patients, at the baseline, mean IPSS was 15.5 (±5.3), vs. 8.6 (±4.4) after mPVP (p = 1 × 10-6), and uroflowmetry 11.7 mL/s (±4), vs. 17.4 (±5.4) (p = 1.4 × 10-5). We did not experience any difficulty for BrT. Mean IPSS did not significantly increase 1, 3, or 6 months after BrT. With a median followup of 60 months [30-120], (92% assessed at last followup), only 4 patients (4/48 = 8.3%) experienced urinary retention and 5 (10.4%) needed surgery for urinary toxicity. In addition, only 2 patients (4%) needed medical treatment at last followup. Considering the 8 patients with de novo incontinence at 1 year, only 2 (4%) had persistent mild symptoms at last followup (36 months) (ICS1-2). CONCLUSIONS: These results suggest that a two-step approach with an mPVP at least 6 weeks before BrT is feasible, with no excessive urinary toxicity, and may be a good strategy for obstructive patients seeking BrT.

Long survival of patients with metastatic clear cell renal cell carcinoma. Results of real life study of 344 patients.

The treatment landscape in metastatic renal cell carcinoma has changed fundamentally over the last decade by the development of antiangiogenic agents, mammalian target of rapamycin inhibitors and immunotherapy. Outside of the context of a clinical trial, the treatments are used sequentially. We describe results under real-life conditions of a sequential treatment strategy, before the era of immunotherapy. All patients were treated according to their prognostic score (either Memorial Sloan Kettering Cancer Center or International Metastatic Renal Cell Carcinoma Database Consortium) for advanced renal cell carcinoma. A treatment strategy involving 1 to 4 lines was determined including a rechallenge criterion for the repeat use of a treatment class. Three hundred forty-four patients were included over 3 years. Overall survival was 57 months in patients with good or intermediate prognosis and 19 months in patients with poor prognosis. In the former group, the proportions of patients treated with 2 to 4 treatment lines were 70%, 38% and 16%, respectively. The best objective response rates for lines 1 to 4 were 46%, 36%, 16% and 17%, respectively. Grade III/IV toxicity did not appear to be cumulative. The recommended strategy was followed in 68% of patients. A large proportion of patients with good or intermediate prognosis who progress after two lines of treatment still have a performance status good enough to receive a systemic treatment, which justifies such a strategy. Overall survival of patients with good and intermediate prognosis was long, suggesting a benefit from the applied approach. These results might be used as selection criterion for the treatment of patients in the era of immune checkpoint inhibitors.

Prospective four years of evaluation of erectile function after low-dose-rate prostate brachytherapy using baseline IIEF-5 > 16.

PURPOSE: Prostate brachytherapy (BT) is a validated treatment for localized prostate cancer (CaP) and an attractive therapy option for patients seeking to preserve erectile function (EF). The aim of this paper is to prospectively assess EF evolution during 4 years after BT. MATERIAL AND METHODS: Between February 2007 and July 2012, 179 patients underwent an exclusive Iodine-125 BT, for low-intermediate favorable risk CaP of whom, 102 had an initial international index of erectile function 5 score (IIEF-5) > 16 and were included in the study. Of those, 12.7% received neo-adjuvant hormonotherapy (HT) to decrease the prostate volume. Post-BT intake of phosphodiesterase inhibitors (PDE5i) was not an exclusion criterion. Erectile function was prospectively assessed using a validated questionnaire IIEF-5 before treatment and annually for 4 years. RESULTS: At 1-year follow-up, 54% of patients preserved an IIEF-5 > 16 and only 8% suffered from severe ED. During the next 3 years, the results were not statistically different. The mean IIEF-5 lost 4 points during the first year, 17 vs. 21, and remained stable during the following 3 years. We did not find any significant differences in the proportion of patients treated by PDE5i (18-20%). As for patients with a normal preoperative IIEF-5 (> 21) (n = 52), 35-42% preserved a normal EF and 71-77% maintained an IIEF-5 > 16, including 13-19% of patients who needed PDE5i. Those results were stable for over 4 years. CONCLUSIONS: During the first 4 years after BT, more than half of patients maintained an IIEF-5 > 16, and EF results remained stable. Severe erectile dysfunction (ED) was very rare.

Dose to the penile bulb and individual patient anatomy are predictive of erectile dysfunction in men treated with 125I low dose rate brachytherapy for localized prostate cancer.

Background: To evaluate the occurrence of erectile dysfunction at 3 years (3yED) after prostate brachytherapy (BT) and to predict 3yED after treatment based on patients and treatments characteristics. Material and methods: From September 2007 to July 2015, 117 men with mild or no ED [International Index of Erectile Function (IIEF-5) > 16] underwent 125Iodine real-time ultrasound-guided low-dose rate BT to a total dose of 160 Gy for low-risk or favorable intermediate-risk prostate adenocarcinoma, and were followed prospectively during 3 years. Median age was 63 years (51-79). The post-implant dosimetric parameters on the postoperative computer tomography were derived from the dose-volume histogram of the prostate and the penile bulb (PB), crura, neurovascular bundles (NVBs) and internal pudendal arteries (IPAs). Potential clinical confounding factors were collected. Additionally, anatomical indexes reflecting the prostate anatomical location within the pelvis were studied. These variables were compared between patients with and without 3yED. 3yED was defined as an IIEF-5 score change to the lower category between baseline, with or without medication. Results: The 3yED rate was 59% (62% maintained an IIEF-5 > 16). On multivariate analysis, prostate D90% (p > .5) and pretreatment characteristics including age (p > .5), pre-implant potency (p > .5), diabetes (p = .08) and high cardiovascular risk rates (p = .1) did not influence the occurrence of 3yED. Only the PB dose especially the D10% > 51 Gy was associated with 3yED (p = .005). Conversely, dose to the crura, IPAs or NVBs did not seem to impact the erectile function. The prostate position, especially the apex location varied significantly between potent and impotent patients and 3yED was significantly associated with close position of the prostate apex to PB (p = .008). Conclusion: The most predictive factor of 3yED was the dose to the PB. This may be explained by variation in individual patients' anatomy and this could allow for the development of better strategies to prevent ED.

Feasibility Study and Preliminary Results of Prognostic Value of Bone SPECT-CT Quantitative Indices for the Response Assessment of Bone Metastatic Prostate Carcinoma to Abiraterone.

Objective: We assessed the prognostic value of quantitative indices extracted from bone SPECT-CT to evaluate the response of bone metastatic castrate-resistant prostate cancer (BmCRPC) to abiraterone. Methods: Consecutive patients with BmCRPC initiating treatment with abiraterone from March 2014 to March 2015 were prospectively included. Three 2-bed SPECT-CT [at baseline [M0], after 3 months [M3], and 6 months [M6] of treatment], were planned (Symbia Intevo®, Siemens). SPECT data were reconstructed using an Ordered Subset Conjugate Gradient Minimization (OSCGM) algorithm allowing SUV quantification. SUVmax and SUVpeak of the highest uptake lesion were measured in each SPECT-CT. Total Neoplastic Osteoblastic Metabolic Volume (NOMV) was assessed. PSA level was recorded at baseline, M3, and M6 of treatment. Overall survival (OS), progression-free survival (PFS), and disease-specific survival (DSS) were calculated. Results: Nineteen patients aged 71.1 ± 7.7 years were included. Low M0 SUVmax was significantly predictive of longer OS (p = 0.04). Low NOMV at M0 were significantly predictive of longer PFS (p = 0.02). Patients with increase of at least 12.5% of the SUVpeak of the highest uptake lesion between M0 and M3 (ΔSUVpeakM0M3) had a significantly longer OS (p = 0.03). Patients with increase (or decrease lesser than 25%) of ΔSUVpeakM0M3 had a significantly longer DSS (p = 0.01). Patients with increase of NOMV of at least 45% between M0 and M6 had a significantly shorter PFS (p < 0.001). Variations of NOMV between M0 and M6 were significantly correlated with PSA variations between M0 and M6 (rs = 0.73, p = 0.02). Conclusions: Quantitative bone SPECT-CT appears to be a promising tool of BmCRPC assessment. Early flare-up phenomenon seems to predict longer OS.

Evaluation of the "Quadrella" at 3 years: New index to assess functional and oncological performance specific to prostate brachytherapy.

PURPOSE: "Quadrella" index has been recently developed to assess oncological and functional outcomes after prostate brachytherapy (PB). We aimed to evaluate this index at 1, 2, and 3 years, using validated questionnaires, assessed prospectively. METHODS AND MATERIALS: From 08/2007 to 01/2013, 193 patients underwent 125Iodine PB for low-risk or favorable intermediate-risk prostate adenocarcinoma. Inclusion criteria were as follows: no incontinence (International Continence Society Index initial score = 0) and good erectile function (International Index of Erectile Function-5 items: >16). One hundred patients were included (mean age: 64 y). Postimplantation intake of phosphodiesterase inhibitors was not considered as failure. The "Quadrella" index was defined by the absence of biochemical recurrence (Phoenix criteria), significant erectile dysfunction (ED) (Index of Erectile Function-5 items: >16), urinary toxicity (UT) (International Prostate Score Symptom [IPSS] <15 or IPSS> 15 with ΔIPSS <5), and rectal toxicity (RT) (Radiation Therapy Oncology Group = 0). RESULTS: At 12 months, 90 patients were evaluable: 42/90 (46.7%) achieved Quadrella. The main criteria for failure were as follows: ED in 77.1% (37/48) of cases, RT in 20.8% (10/48) of cases, and UT in 12.5% (9/57) of cases. At 24 and 36 months, 59.3% (48/81) and 61.1% (44/72) of patients achieved Quadrella, respectively. The main cause of failure was ED in 69.7% (23/33) and 85.7% (24/28) of cases, while RT was involved in 21.2% (7/33) and in 3.6% (1/28) of cases, and UT in 9.1% (3/33) and 3.6% (1/28) of cases. Only one case of biochemical recurrence was observed (i.e., 1/28 = 3.6% at 3 y). CONCLUSIONS: The Quadrella can be used at 1, 2, and 3 years after PB. It allows to take into account the urinary and RT specific to PB. ED was the main cause of failure. This index will be useful to assess midterm and long-term results.

Prediction of outcome using pretreatment 18F-FDG PET/CT and MRI radiomics in locally advanced cervical cancer treated with chemoradiotherapy.

PURPOSE: The aim of this study is to determine if radiomics features from 18fluorodeoxyglucose (FDG) positron emission tomography/computed tomography (PET/CT) and magnetic resonance imaging (MRI) images could contribute to prognoses in cervical cancer. METHODS: One hundred and two patients (69 for training and 33 for testing) with locally advanced cervical cancer (LACC) receiving chemoradiotherapy (CRT) from 08/2010 to 12/2016 were enrolled in this study. 18F-FDG PET/CT and MRI examination [T1, T2, T1C, diffusion-weighted imaging (DWI)] were performed for each patient before CRT. Primary tumor volumes were delineated with the fuzzy locally adaptive Bayesian algorithm in the PET images and with 3D Slicer™ in the MRI images. Radiomics features (intensity, shape, and texture) were extracted and their prognostic value was compared with clinical parameters for recurrence-free and locoregional control. RESULTS: In the training cohort, median follow-up was 3.0 years (range, 0.43-6.56 years) and relapse occurred in 36% of patients. In univariate analysis, FIGO stage (I-II vs. III-IV) and metabolic response (complete vs. non-complete) were probably associated with outcome without reaching statistical significance, contrary to several radiomics features from both PET and MRI sequences. Multivariate analysis in training test identified Grey Level Non UniformityGLRLM in PET and EntropyGLCM in ADC maps from DWI MRI as independent prognostic factors. These had significantly higher prognostic power than clinical parameters, as evaluated in the testing cohort with accuracy of 94% for predicting recurrence and 100% for predicting lack of loco-regional control (versus ~50-60% for clinical parameters). CONCLUSIONS: In LACC treated with CRT, radiomics features such as EntropyGLCM and GLNUGLRLM from functional imaging DWI-MRI and PET, respectively, are independent predictors of recurrence and loco-regional control with significantly higher prognostic power than usual clinical parameters. Further research is warranted for their validation, which may justify more aggressive treatment in patients identified with high probability of recurrence.

Target definition in salvage postoperative radiotherapy for prostate cancer: 18F-fluorocholine PET/CT assessment of local recurrence.

PURPOSE: Inadequate clinical target volume (CTV) definition is likely to be a major contributing factor to local recurrence (LR) rate after radiotherapy. Our aims were to identify sites of prostate cancer LR in biochemical recurrence post-prostatectomy using 18F-Fluorocholine (18F-FCH) positron emission tomography/computed tomography (PET/CT) and to compare different CTV-delineation guidelines in a cohort of postoperative patients. MATERIAL AND METHODS: Thirty-six patients presenting with LR within the prostatic bed on 18F-FCH PET/CT between 10/2011 and 06/2016 were included in this retrospective study. Median PSA at the time of 18F-FCH PET/CT was 2.7 ng/mL (0.8-9.4) and median PSA doubling time was 11 months (3-28). For each patient, the CTVRTOG, CTVFROGG and CTVEORTC following the corresponding guidelines were outlined and compared. Forty-one LR were delineated using a gradient-based method and the percentage of FCH uptake included in each CTV was evaluated. RESULTS: The anastomosis was the most common recurrence site (52.8%), followed by the retrovesical region (31.7%) and the bladder neck (7%). The median SUV max value was 4.8 (2.3-16.1). The percentage of LR entirely included in the CTVRTOG was not significantly different from that included in the CTVFROGG (84% versus 83%, p = .5). Significantly more recurrences were included in the CTVRTOG volume compared to the CTVEORTC (84% versus 68%, p=.006), due to a better coverage of the bladder neck and retrovesical regions. Six out of 10 relapses occurring in the posterior region of the anastomosis were not covered by any of the CTVs. CONCLUSIONS: In our study, the CTVRTOG and CTVFROGG ensured the best coverage of LR seen on 18F-FCH PET/CT. When outlining the prostatic fossa, greater coverage of the posterior vesico-urethral region may allow better coverage of potential microscopic disease.

Personalised chemotherapy based on tumour marker decline in poor prognosis germ-cell tumours (GETUG 13): a phase 3, multicentre, randomised trial.

BACKGROUND: Poor prognosis germ-cell tumours are only cured in about half of patients. We aimed to assess whether treatment intensification based on an early tumour marker decline will improve progression-free survival for patients with germ-cell tumours. METHODS: In this phase 3, multicentre, randomised trial, patients were enrolled from France (20 centres), USA (one centre), and Slovakia (one centre). Patients were eligible if they were older than 16 years, had evidence of testicular, retroperitoneal, or mediastinal non-seminomatous germ cell tumours based on histological findings or clinical evidence and highly elevated serum human chorionic gonadotropin or alfa-fetoprotein concentrations that matched International Germ Cell Cancer Consensus Group poor prognosis criteria. After one cycle of BEP (intravenous cisplatin [20 mg/m(2) per day for 5 days], etoposide [100 mg/m(2) per day for 5 days], and intramuscular or intravenous bleomycin [30 mg per day on days 1, 8, and 15]), patients' human chorionic gonadotropin and alfa-fetoprotein concentrations were measured at day 18-21. Patients with a favourable decline in human chorionic gonadotropin and alfa-fetoprotein continued BEP (Fav-BEP group) for 3 additonal cycles, whereas patients with an unfavourable decline were randomly assigned (1:1) to receive either BEP (Unfav-BEP group) or a dose-dense regimen (Unfav-dose-dense group), consisting of intravenous paclitaxel (175 mg/m(2) over 3 h on day 1) before BEP plus intravenous oxaliplatin (130 mg/m(2) over 3 h on day 10; two cycles), followed by intravenous cisplatin (100 mg/m(2) over 2 h on day 1), intravenous ifosfamide (2 g/m(2) over 3 h on days 10, 12, and 14), plus mesna (500 mg/m(2) at 0, 3, 7 and 11 h), and bleomycin (25 units per day, by continuous infusion for 5 days on days 10-14; two cycles), with granulocyte-colony stimulating factor (lenograstim) support. Centrally blocked computer-generated randomisation stratified by centre was used. The primary endpoint was progression-free survival and the efficacy analysis was done in the intention-to-treat population. The planned trial accrual was completed in May, 2012, and follow-up is ongoing. This study is registered with ClinicalTrials.gov, number NCT00104676. FINDINGS: Between Nov 28, 2003, and May 16, 2012, 263 patients were enrolled and 254 were available for tumour marker assessment. Of these 51 (20%) had a favourable marker assessment, and 203 (80%) had an unfavourable tumour marker decline; 105 were randomly assigned to the Unfav-dose-dense group and 98 to the Unfav-BEP group. 3-year progression-free survival was 59% (95% CI 49-68) in the Unfav-dose-dense group versus 48% (38-59) in the Unfav-BEP group (HR 0·66, 95% CI 0·44-1·00, p=0·05). 3-year progression-free survival was 70% (95% CI 57-81) in the Fav-BEP group (HR 0·66, 95% CI 0·49-0·88, p=0·01 for progression-free survival compared with the Unfav-BEP group). More grade 3-4 neurotoxic events (seven [7%] vs one [1%]) and haematotoxic events occurred in the Unfav-dose-dense group compared with in the Unfav-BEP group; there was no difference in grade 1-2 febrile neutropenia (18 [17%] vs 18 [18%]) or toxic deaths (one [1%] in both groups). Salvage high-dose chemotherapy plus a stem-cell transplant was required in six (6%) patients in the Unfav-dose-dense group and 16 (16%) in the Unfav-BEP group. INTERPRETATION: Personalised treatment with chemotherapy intensification reduces the risk of progression or death in patients with poor prognosis germ-cell tumours and an unfavourable tumour marker decline. FUNDING: Institut National du Cancer (Programme Hospitalier de Recherche Clinique).

A risk-adapted study of cisplatin and etoposide, with or without ifosfamide, in patients with metastatic seminoma: results of the GETUG S99 multicenter prospective study.

BACKGROUND: Whether patients with good prognosis and intermediate/poor prognosis advanced seminoma should be treated differently has not been defined. OBJECTIVE: To assess a risk-adapted chemotherapy regimen in patients with advanced seminoma. DESIGN, SETTING, AND PARTICIPANTS: A total of 132 patients were included in this prospective study. Patients with a good prognosis according to the International Germ Cell Cancer Collaboration Group (IGGCCG) were treated with four cycles of cisplatin-etoposide (EP). Patients with an intermediate prognosis according to the IGCCCG (or a poor prognosis according to the Medical Research Council classification) were treated with four cycles of VIP (EP and ifosfamide) and granulocyte colony-stimulating factor (G-CSF). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Survival curves were estimated using the Kaplan-Meier method. RESULTS AND LIMITATIONS: The median follow-up was 4.5 yr (range: 0.4-11.6 yr). Among 108 patients (82%) with a good prognosis who received EP, grade 3-4 toxicity included neutropenia (47%) and neutropenic fever (12%). Among the 24 patients (18%) with an intermediate/poor prognosis who received VIP plus G-CSF, toxicity included grade 3-4 neutropenia (36%), neutropenic fever (23%), thrombocytopenia (23%), anemia (23%), and a toxicity-related death (n=1; 4%). The 3-yr progression-free survival (PFS) rate was 93% (range: 85-97%) in the good prognosis group and 83% (range: 63-93%) in the intermediate/poor prognosis group (p=0.03 for PFS). The 3-yr overall survival (OS) rate was 99% (range: 92-100%) and 87% (range: 67-95%), respectively (p<0.005 for OS). Only four patients died of seminoma or its treatment. CONCLUSIONS: A risk-adapted chemotherapy policy for advanced seminoma yielded an excellent outcome with a 3-yr OS rate of 96%.

Impact of experience and technical changes on acute urinary and rectal morbidity in low-dose prostate brachytherapy using loose seeds real-time implantation.

PURPOSE: To assess the impact of experience and technical changes on morbidity during the first year after permanent prostate brachytherapy. METHODS AND MATERIALS: From July 2003 to May 2010, 150 patients with prostate cancer underwent low-dose iodine-125 prostate brachytherapy as a monotherapy by the same medical team (one urologist and one radiation oncologist). Patients were divided into three periods: P1 (n = 64), P2 (n = 45), and P3 (n = 41) according to technical changes: use of an automatic stepper from P2, use of a high-frequency ultrasound probe in P3. Urinary toxicity was analyzed according to the incidence of acute urinary retention (AUR), Delta International Prostate Symptom Score (Δ IPSS) defined as IPPS maximal - IPSS at baseline, and proportion of patients with Δ IPSS ≥5 and IPSS total >15. The Radiation Therapy Oncology Group classification was used to evaluate the rectal morbidity. RESULTS: The incidence of AUR (6% overall) decreased significantly with time: 12.5% (8/64) during P1, 2.2% (1/45) in P2, and 0% in P3 (p = 0.014). Mean Δ IPSS (11.6) remained stable during the three periods. Patients with Δ IPSS ≥5 and IPSS total >15 were 58.7%, 58.1%, and 56.1% for P1, P2, and P3 (p = 0.96), respectively. Grade 1 and 2 proctitis were observed in 15.3% and 9.3% of the patients without any significant difference between the three periods. CONCLUSION: The incidence of AUR decreased significantly with time. This was probably because of the experience of the practitioner and the use of an automatic stepper that allowed reducing prostatic traumatism. Experience and technical changes did not seem to affect rectal morbidity.

Impact of the per-operatory application of GLIADEL wafers (BCNU, carmustine) in combination with temozolomide and radiotherapy in patients with glioblastoma multiforme: efficacy and toxicity.

PURPOSE: For the last few years wafers of Gliadel have been inserted into the operation cavity in patients with glioblastoma multiforme. This is followed by concurrent radio-chemotherapy with temozolomide (TMZ) according to the Stupp protocol. Only a few studies have investigated this kind of treatment regimen and the impact in terms of survival and toxicity of the combination of Gliadel with TMZ and radiotherapy. METHODS AND MATERIALS: From November 2006 to January 2010, 24 patients with a newly diagnosed glioblastoma have undergone a tumour resection which was considered to be macroscopically complete in 12 cases and with tumour residue in another 12 cases. The mean age at the moment of diagnosis was 60.25years and the median age 63. Twenty-three patients underwent subsequently concurrent radio-chemotherapy with TMZ followed by cycles of elevated doses of TMZ as an adjuvant treatment. One patient had adjuvant radiotherapy alone followed by adjuvant chemotherapy. Thirteen were able to receive 6 or more cycles of adjuvant TMZ. Seven patients had received less than 6 cycles of TMZ as an adjuvant therapy. Two patients did not receive adjuvant TMZ at all. RESULTS: The median overall survival of our group was 19.2months and the median progression free survival was 12.3months. Overall survival for the macroscopically complete-resection patients was 14months, and 12.85months in subtotal-resection patients. The median OS was 14.25months for patients PS 0 - 1 at the moment of diagnosis and 12.65 for PS 2 patients. Chemotherapy with TMZ had to be stopped prematurely in 10 cases due to haematotoxicity, digestive toxicity or early relapse. CONCLUSIONS: The concomitant use of surgery with implantation of BCNU wafers and radio-chemotherapy seems to be well tolerated. Despite the small number of patients treated in our group, particular attention should be paid to the potential haematological consequences of this multimodal treatment regimen.

Results of the GYNECO 02 study, an FNCLCC phase III trial comparing hysterectomy with no hysterectomy in patients with a (clinical and radiological) complete response after chemoradiation therapy for stage IB2 or II cervical cancer.

BACKGROUND: Concomitant chemoradiation (CRT) (including brachytherapy) is considered the standard management for stage IB2 or II cervical cancer in many countries. Nevertheless, some of them discuss completion surgery (hysterectomy [HT]) after CRT. The aim of this study was to investigate the therapeutic impact of such surgery. METHODS: A randomized trial was opened in France in 2003 to evaluate the interest in HT after CRT. Inclusion criteria were: (a) stage IB2 or II cervical cancer without extrapelvic disease on conventional imaging; (b) pelvic external radiation therapy (45 Gy with or without parametrial or nodal boost) with concomitant cisplatin chemotherapy (40 mg/m2 per week) followed by uterovaginal brachytherapy (15 Gy to the intermediate risk clinical target volume); and (c) complete clinical and radiological response 6-8 weeks after brachytherapy. Patients were randomized between HT (arm A) and no HT (arm B). Unfortunately this trial was closed because of poor accrual: 61 patients were enrolled (in 2003-2006) and are reported on here. RESULTS: Thirty one and 30 patients were enrolled, respectively, in arm A and arm B. Twelve patients recurred (five of them died): respectively, eight and four in arm A and arm B. The 3-year event-free survival rates were 72% (standard error [SE], 9%) and 89% (SE, 6%) (not significant [NS]) in arm A and arm B, respectively. The 3-year overall survival rates were 86% (SE, 6%) and 97% (SE, 3%) (NS) in arm A and arm B, respectively. CONCLUSIONS: Results of the current trial seem to suggest that completion HT had no therapeutic impact in patients with clinical and radiological complete response after CRT (but this conclusion is limited by the lack of power).

Post-fracture osteolysis of the pubic bone simulating a malignancy: report of a case.

Post-fracture osteolysis of the pubic bone is rare. We report a case of a 70-year-old woman with osteoporosis and a history of radiation therapy 2 years earlier. At presentation, she was found to have a bilateral sacral fracture and fractures of both pubic rami on one side. The pain persisted, and follow-up radiographs showed osteolysis of the pubic rami suggestive of metastatic disease. The development of a bony callus within 8 months established the diagnosis of benign osteolysis. About 50 cases of osteolysis at fracture sites have been reported to date, of which about a dozen occurred after radiation therapy. All the patients were elderly women with post-menopausal osteoporosis. Radiation therapy probably further increases the risk in this setting. The possibility of osteolysis at fracture sites in patients with osteoporosis should be borne in mind to avoid unnecessary and burdensome investigations that are costly and cause undue anxiety to the patients. Rest is the only effective treatment.