Cost-effectiveness of weekly adaptive radiotherapy versus standard IMRT in head and neck cancer alongside the ARTIX trial.

BACKGROUND AND PURPOSE: We performed a cost-effectiveness analysis (CEA) comparing an adaptive radiotherapy (ART) strategy, based on weekly replanning, aiming to correct the parotid gland overdose during treatment and expecting therefore to decrease xerostomia, when compared to a standard IMRT. MATERIALS AND METHODS: We conducted the ARTIX trial, a randomized, parallel-group, multicentric study comparing a systematic weekly replanning ART to a standard IMRT. The primary endpoint was the frequency of xerostomia at 12 months, measured by stimulating salivary flow with paraffin. The CEA was designed alongside the ARTIX trial which was linked to the French national health data system (SNDS). For each patient, healthcare consumptions and costs were provided by the SNDS. The reference case analysis was based on the primary endpoint of the trial. Sensitivity and scenario analyses were performed. RESULTS: Of the 129 patients randomly assigned between 2013 and 2018, only 2 records were not linked to the SNDS, which provides a linkage proportion of 98.4%. All of the other 127 records were linked with good to very good robustness. On the intent-to-treat population at 12 months, mean total costs per patient were €41,564 (SD 23,624) and €33,063 (SD 16,886) for ART and standard IMRT arms, respectively (p = 0.033). Incremental cost effectiveness ratio (ICER) was €162,444 per xerostomia avoided. At 24 months, ICER was €194,521 per xerostomia avoided. For both progression-free and overall survival, ART was dominated by standard IMRT. CONCLUSION: The ART strategy was deemed to be not cost-effective compared with standard IMRT for patients with locally advanced oropharyngeal cancer.

Randomized phase III trial of metabolic imaging-guided dose escalation of radio-chemotherapy in patients with newly diagnosed glioblastoma (SPECTRO GLIO trial).

BACKGROUND: Glioblastoma (GBM) systematically recurs after a standard 60 Gy radio-chemotherapy regimen. Since magnetic resonance spectroscopic imaging (MRSI) has been shown to predict the site of relapse, we analyzed the effect of MRSI-guided dose escalation on overall survival (OS) of patients with newly diagnosed GBM. METHODS: In this multicentric prospective phase III trial, patients who had undergone biopsy or surgery for a GBM were randomly assigned to a standard dose (SD) of 60 Gy or a high dose (HD) of 60 Gy with an additional simultaneous integrated boost totaling 72 Gy to MRSI metabolic abnormalities, the tumor bed and residual contrast enhancements. Temozolomide was administered concomitantly and maintained for 6 months thereafter. RESULTS: One hundred and eighty patients were included in the study between March 2011 and March 2018. After a median follow-up of 43.9 months (95% CI [42.5; 45.5]), median OS was 22.6 months (95% CI [18.9; 25.4]) versus 22.2 months (95% CI [18.3; 27.8]) for HD, and median progression-free survival was 8.6 (95% CI [6.8; 10.8]) versus 7.8 months (95% CI [6.3; 8.6]), in SD versus HD, respectively. No increase in toxicity rate was observed in the study arm. The pseudoprogression rate was similar across the SD (14.4%) and HD (16.7%) groups. For O(6)-methylguanine-DNA methyltransferase (MGMT) methylated patients, the median OS was 38 months (95% CI [23.2; NR]) for HD patients versus 28.5 months (95% CI [21.1; 35.7]) for SD patients. CONCLUSION: The additional MRSI-guided irradiation dose totaling 72 Gy was well tolerated but did not improve OS in newly diagnosed GBM. TRIAL REGISTRATION: NCT01507506; registration date: December 20, 2011. https://clinicaltrials.gov/ct2/show/NCT01507506?cond=NCT01507506&rank=1.

Weekly Adaptive Radiotherapy vs Standard Intensity-Modulated Radiotherapy for Improving Salivary Function in Patients With Head and Neck Cancer: A Phase 3 Randomized Clinical Trial.

Importance: Xerostomia is a major toxic effect associated with intensity-modulated radiotherapy (IMRT) for oropharyngeal cancers. Objective: To assess whether adaptive radiotherapy (ART) improves salivary function compared with IMRT in patients with head and neck cancer. Design, Setting, and Participants: This phase 3 randomized clinical trial was conducted in 11 French centers. Patients aged 18 to 75 years with stage III-IVB squamous cell oropharyngeal cancer treated with chemoradiotherapy were enrolled between July 5, 2013, and October 1, 2018. Data were analyzed from November 2021 to May 2022. Interventions: The patients were randomly assigned (1:1) to receive standard IMRT (without replanning) or ART (systematic weekly replanning). Main Outcomes and Measures: The primary end point was the frequency of xerostomia, measured by stimulating salivary flow with paraffin. Secondary end points included salivary gland excretory function measured using technetium-99m pertechnetate scintigraphy, patient-reported outcomes (Eisbruch xerostomia-specific questionnaire and the MD Anderson Symptom Inventory for Head and Neck Cancer questionnaire), early and late toxic effects, disease control, and overall and cancer-specific survival. Results: A total of 132 patients were randomized, and after 1 exclusion in the ART arm, 131 were analyzed: 66 in the ART arm (mean [SD] age at inclusion, 60 [8] years; 57 [86.4%] male) and 65 in the standard IMRT arm (mean [SD] age at inclusion, 60 [8] years; 57 [87.7%] male). The median follow-up was 26.4 months (IQR, 1.2-31.3 months). The mean (SD) salivary flow (paraffin) at 12 months was 630 (450) mg/min in the ART arm and 584 (464) mg/min in the standard arm (P = .64). The mean (SD) excretory function of the parotid gland at 12 months, measured by scintigraphy, improved in the ART arm (48% [17%]) compared with the standard arm (41% [17%]) (P = .02). The 2-year-overall survival was 76.9% (95% CI, 64.7%-85.4%) in both arms. Conclusions and Relevance: This randomized clinical trial did not demonstrate a benefit of ART in decreasing xerostomia compared with standard IMRT. No significant differences were found in secondary end points except for parotid gland excretory function, as assessed by scintigraphy, or in survival rates. Trial Registration: ClinicalTrials.gov Identifier: NCT01874587.

Efficacy and tolerance of thoracic radiotherapy in the oldest old patients: A case series.

BACKGROUND: There are only scarce data on the management of nonagenarians with lung cancer, and more particularly on the place of radiation therapy. The aim of the present study was to retrospectively evaluate the efficacy and tolerance of radiotherapy (RT) in nonagenarians with thoracic cancer. PATIENTS AND METHODS: Records from RT departments from four institutions were reviewed to identify patients 90 years old of age and older undergoing RT over the past decade for thoracic cancer and more particularly lung cancer. Tumors' characteristics as well as treatment specificities and its intent were examined. RESULTS: Thirteen patients receiving RT courses were identified, mean age 91.9 years. Treatment was given with curative and palliative intent in 15.4% and 84.6%, respectively. The median total prescribed dose was 30 Gy (4-70). The median number of fractions was equal to 10 (1-35). The median dose received for each fraction was 3 Gy (1.7-7). RT could not be completed in 2 patients (15.4%). At last follow-up, 11 patients (76.9%) were deceased, cancer being the cause of death for 90% of them. Most toxicities were grade 1 or 2. Two patients (15.4% of cases) have developed grade 2 toxicity during treatment. One patient (7.7% of cases) experienced an acute grade 3 toxicity. CONCLUSION: The study shows that RT for thoracic cancer is feasible in nonagenarians. Although the definitive benefit of RT could not be addressed here, hypofractionated therapy allowed a certain measure of control with acceptable side effects.

Radiotherapy for gynecologic cancer in nonagenarian patients: a framework for new paradigms.

No consensus exists regarding the role of radiotherapy in the management of gynecologic cancer in nonagenarian patients. We retrospectively reviewed the outcomes of 19 consecutive nonagenarian patients with gynecologic cancer (6 endometrial cancers, 6 cervical cancers, 4 vulvar cancers, and 3 vaginal cancers) who were treated with radiotherapy. Radiotherapy was performed mainly in a palliative setting (n = 12; 63.2%), with a median dose of 45 Gy (range, 6-76 Gy). Infrequent major acute or late toxicities were reported. Among 19 patients, 9 (47.4%) experienced tumor progression, 5 (26.3%) experienced complete response, 2 (10.5%) experienced stable disease and/or partial response. At last follow-up, 12 patients (63.2%) had died; most deaths (n = 9) occurred because of the cancer. These results suggest that radiotherapy is feasible in the treatment of nonagenarian patients with gynecologic cancer.

Intensity-modulated radiotherapy or volumetric-modulated arc therapy in patients with head and neck cancer: Focus on salivary glands dosimetry.

BACKGROUND: Despite radiotherapy (RT) technical improvements, high salivary dysfunction rates are still reported in patients with head and neck squamous cell carcinoma (HNSCC). The purpose of the present study was to report salivary glands dosimetry with volumetric-modulated arc therapy (VMAT) and intensity-modulated RT (IMRT). METHODS: Dosimetry of consecutive patients receiving IMRT or VMAT for proven HNSCC between 2007 and 2013 were retrospectively reviewed. RESULTS: Data of 609 patients were studied. Mean dose, mean maximum dose, and mean percentage of salivary gland volume receiving at least 26 Gy (V26) of the contralateral parotid were 24.50 Gy (range, 0-70.4 Gy), 39.08 Gy (range, 0.38-76.45 Gy), and 40.92% (range, 0% to 100%), respectively. Mean and maximum dose on contralateral submandibular gland were 48.18 Gy (range, 0.19-70.73 Gy), and 61.25 Gy (range, 0-75.8 Gy), respectively. CONCLUSION: Target volume coverage still has to be prioritized over organs at risk (OAR) sparing with new RT techniques. Submandibular glands are not sufficiently taken into account in guidelines. © 2016 Wiley Periodicals, Inc. Head Neck 38: 1028-1034, 2016.

Dosimetric study of volumetric arc modulation with RapidArc and intensity-modulated radiotherapy in patients with cervical cancer and comparison with 3-dimensional conformal technique for definitive radiotherapy in patients with cervical cancer.

INTRODUCTION: For patients with cervical cancer, intensity-modulated radiation therapy (IMRT) improves target coverage and allows dose escalation while reducing the radiation dose to organs at risk (OARs). In this study, we compared dosimetric parameters among 3-dimensional conformal radiotherapy (3D-CRT), "step-and-shoot" IMRT, and volumetric intensity-modulated arc radiotherapy (VMAT) in a series of patients with cervical cancer receiving definitive radiotherapy. Computed tomography (CT) scans of 10 patients with histologically proven cervical cancer treated with definitive radiation therapy (RT) from December 2008 to March 2010 at our department were selected for this study. The gross tumor volume (GTV) and clinical target volume (CTV) were delineated following the guidelines of the Gyn IMRT consortium that included cervix, uterus, parametrial tissues, and the pelvic nodes including presacral. The median age was 57 years (range: 30 to 85 years). All 10 patients had squamous cell carcinoma with Federation of Gynecology and Obstetrics (FIGO) stage IB-IIIB. All patients were treated by VMAT. OAR doses were significantly reduced for plans with intensity-modulated technique compared with 3D-CRT except for the dose to the vagina. Between the 2 intensity-modulated techniques, significant difference was observed for the mean dose to the small intestine, to the benefit of VMAT (p < 0.001). There was no improvement in terms of OARs sparing for VMAT although there was a tendency for a slightly decreased average dose to the rectum: - 0.65Gy but not significant (p = 0.07). The intensity modulation techniques have many advantages in terms of quality indexes, and particularly OAR sparing, compared with 3D-CRT. Following the ongoing technologic developments in modern radiotherapy, it is essential to evaluate the intensity-modulated techniques on prospective studies of a larger scale.

Hypofractionated radiation therapy for treatment of bladder carcinoma in patients aged 90 years and more: A new paradigm to be explored?

INTRODUCTION: There are only scarce data on the optimal management of patients who present with a bladder carcinoma and who are aged 90 years and older. PATIENTS AND METHODS: We retrospectively reviewed records from radiotherapy departments from two university hospitals, two private centers and one public center to identify patients who underwent radiotherapy for bladder cancer over the past decade and who were aged 90 years or older. From 2003 to 2013, 14 patients aged 90 years or older receiving RT for bladder malignant tumors were identified. RESULTS: Mean age was 92.7 years. Ten patients (71 %) had a general health status altered (PS 2-3) at the beginning of RT. A total of 14 RT courses were delivered, including six treatments (43 %) with curative intent and eight treatments (57 %) with palliative intent. Palliative intent mainly encompassed hemostatic RT (36 %). At last follow-up, two patients (14 %) experienced complete response, one patient (7 %) experienced partial response, three patients (21 %) had their disease stable, and three patients (21 %) experienced tumor progression, of whom two patients with the progression of symptoms. There was no reported high-grade acute local toxicity in 14 patients (100 %). One patient experienced delayed grade 2 toxicity with pain and lower urinary tract symptoms. At last follow-up, seven patients (50 %) were deceased. Cancer was the cause of death for five patients. CONCLUSION: Hypofractionated radiotherapy remains feasible for nonagenarians with bladder cancer. Further investigations including analysis of geriatric comorbidities and impact of treatments on quality of life should be conducted.

Radiotherapy for head and neck cancer in nonagenarian patients: a possible cornerstone?

In the field of radiotherapy, there is very little scientific data on the management of nonagenarians, especially in patients aged 90 years or more and with head and neck cancer (HNC). We made one of the first retrospective study of the feasibility and safety of radiotherapy in this population with HNC. Records of radiotherapy coming from four health facilities were studied to include all nonagenarian patients with HNC in the last 10 years and who received radiation therapy. We analyzed patient characteristics and primary cancers, as well as objective of the treatment (curative or palliative), efficacy and toxicity. Twenty patients receiving radiotherapy were identified; mean age was 93.2 years (standard deviation 2.8). Treatment was given with curative and palliative intent in 40 and 60 % of cases, respectively. The most common primary tumors were tumors of the salivary glands (30 % of cases), oral cavity tumors (25 % of cases) and thyroid tumors (15 % of cases). Median total prescribed dose was 47.5 Gy (12-70 Gy). Median number of delivered fractions was 18.5 (2-35 fractions). All patients received intensive supportive care during radiotherapy. Toxicities were mild to moderate. Radiotherapy could not be completed for four patients (20 % of cases). One patient developed grade 1-2 delayed toxicities. At the last follow-up, only four patients (20 % of cases) were alive. Cancer was cause of death in most cases. Radiotherapy may be performed for the nonagenarians with HNC. The total dose and fractionation must be adjusted to optimize the tolerance. However, the prognosis remains very poor, cancer being the main cause of death. Research of geriatric vulnerabilities prior to any treatment, in the context of a comprehensive geriatric assessment, is still recommended to select patients for radiotherapy.

General management of nonagenarian patients: a review of the literature.

The number of nonagenarian people in the world is steadily growing. This phenomenon will increase in future years: in 2050, world population prospects estimate 71.16 million people aged 90 years or older. The two main causes of death among people aged 85 years or more in Europe in 2003 were cardiovascular and cerebrovascular diseases and cancers. However, the elderly are often excluded from clinical trials; they are underrepresented in clinical registries and especially nonagenarians. Care (medical, surgical, oncology) of these very elderly is currently insufficiently based on scientific recommendations. For the physician, the choice to treat or not to treat very elderly patients (for fear of side effects) is difficult. Oncology is particularly affected by this problem. Here we review these different fields of internal medicine management of nonagenarian patients with a special focus on oncology and on comprehensive geriatric assessment as a base for all care decision taking.

Portrait, treatment choices and management of breast cancer in nonagenarians: an ongoing challenge.

There are only scarce data on the management of nonagenarians with breast cancer, and more particularly on the place of radiation therapy (RT). We report a retrospective study on patients aged 90 years old or older, with breast cancer, receiving RT. Records from RT departments from five institutions were reviewed to identify patients 90 years old of age and older undergoing RT over past decade for breast cancer. Tumors' characteristics were examined, as well treatment specificities and treatment intent. 44 patients receiving RT courses were identified, mean age 92 years. Treatment was given with curative and palliative intent in 72.7% and 27.3% respectively. Factors associated with a curative treatment were performance status (PS), place of life, previous surgery, and tumor stage. Median total prescribed dose was 40 Gy (23-66). Hypo fractionation was used in 77%. Most toxicities were mild to moderate. RT could not be completed in 1 patient (2.3%). No long-term toxicity was reported. Among 31 patients analyzable for effectiveness, 24 patients (77.4%) had their diseased controlled until last follow-up, including 17 patients (54.8%) experiencing complete response. At last follow-up, 4 patients (12.9%) were deceased, cancer being cause of death for two of them. The study shows that breast/chest RT is feasible in nonagenarians. Although the definitive benefit of RT could not be addressed here, hypofractionated therapy allowed a good local control with acceptable side effects.

Feasibility of radiation therapy in patients 90years of age and older: a French multicentre analysis.

BACKGROUND: There are only scarce data on the management of patients aged 90years or older with cancer, and more particularly on the place of radiation therapy (RT). We report the first large study on patients (pts) aged 90years or older receiving RT. METHODS AND MATERIALS: Records from RT departments from five institutions were reviewed to identify pts 90years of age and older who underwent RT for various malignant tumours treated between 2003 and 2012. Tumours' characteristics were examined, as well as treatment specificities and treatment intent. RESULTS: 308 pts receiving 318 RT courses were identified, mean age was 93.2years (standard deviation 2.8). Treatment was given with curative and palliative intent in 44% and 56%, respectively. Factors associated with a curative treatment were performance status (PS), place of life, previous surgery and tumour stage. Median total prescribed dose was 36Gy (4-76Gy). Hypofractionation and split course were used in 88% and 7.3%, respectively. Most toxicities were mild to moderate. RT could not be completed in 23 pts (7.5%). No long-term toxicity was reported. Median overall survival was 22.9months (95CI: 15.5-42.7months). Cancer was the cause of death in 8.7% and 46% of pts treated with curative and palliative intent, respectively. CONCLUSION: This study shows that RT is feasible for patients aged 90years or more. PS, place of life and tumour stage were factors of the therapeutic decision. There is no reason to withdraw pts with good general health condition from potentially curative RT, provided that careful attention is paid to factors of toxicity and to geriatric vulnerabilities.

[Management of vaginal carcinoma in patients over 70 years old: advantage of a radiotherapy-brachytherapy association]. / Prise en charge du cancer primitif du vagin chez la femme de plus de 70ans: intérêt d'une association radiothérapie-curiethérapie.

OBJECTIVE: Report and discuss the management of the primitive vaginal cancer in elderly adults at a single institute. PATIENTS AND METHODS: Data from patients more than 70 year-old treated for a primitive vaginal cancer at the Institut de Cancérologie de la Loire Lucien-Neuwirth was retrospectively collected. RESULTS: From August 1999 to January 2009, 9/24 patients treated for a primitive vaginal cancer had more than 70 year-old. The median age was 81 years (7-94 years). Most patients had a performance status less or equal to 1 (n=6), a squamous cell carcinoma (n=7) and a FIGO stage less or equal to II (n=6). All patients were treated with 3D external beam radiation, 3 received concurrent chemotherapy, 3 had a supplementary brachytherapy, and 6 had a colpohysterectomy. Among 7 evaluable patients, there were 4 complete responses, 2 partial responses and one progression. Main acute toxicities were gastrointestinal (n=5), urinary (n=3), general (n=3) and cutaneous (n=2). Three patients experienced late toxicities. Four patients had a local recurrence after a mean delay of 10.8 months. At last news, 4 patients were still alive and 4/5 deaths were related to the cancer. All (n=3) patients who received the combination of radiotherapy - brachytherapy were alive and disease-free. Median overall survival was 18 months. DISCUSSION AND CONCLUSIONS: Primitive vaginal cancers are rare and aggressive tumours. Our results suggested the feasibility of the combination of radiotherapy and brachytherapy for elderly patients. Prospective trials remain needed to better define and validate the optimal strategy, especially in elderly adults.

[Evaluation of professional practices: improving cancer related-pain management in radiation oncology]. / Évaluation des pratiques professionnelles : améliorer la prise en charge de la douleur liée au cancer en oncologie radiothérapie.

Radiation oncologist often faced cancer pain, regardless the stage of cancer. Given the high prevalence of cancer pain, and its potential for profound adverse consequences, all patients with active malignancy should be routinely screened and treated for pain. Using a questionnaire developed by the pain center of the Institut de cancérologie de la Loire, we questioned in a routine day 154 patients receiving radiation in our department. On 154 assessed patients, 92% (n = 143) were treated with curative intent and 8% (n = 11) with analgesic intent. Sixty-seven (44%) and 14 (9%) declared to feel pain outside and during radiotherapy, respectively. Using the visual analogic scale, 39, 41 and 20% rated their pain between 1 and 3, 4 and 6 and more than 7, respectively. One third of patients suffering from pain had no analgesic treatment and 55% of patients felt inadequately relieved. Almost all (97%) of these noted an impact on their quality of life. Half of them (54%) were aware of a specific consultation for pain. A pain consultation was offered to 19% of respondents and 26% of patients were referred for a specialized consultation at the end of the investigation. Despite the existence of a pain center in the Institute, the pain seems insufficiently assessed and supported for patients receiving radiation therapy. Better communication between caregivers and better information should enable a more comprehensive assessment and specific treatment for cancer-pain related.

[Establishment of a pilot study of awareness retraining in physical activity in two selected populations of patients with breast cancer]. / Mise en place d'une étude pilote de sensibilisation au réentraînement à l'activité physique dans deux populations sélectionnées atteintes d'un cancer du sein.

The purpose of this study is to measure the impact of an educational program to raise awareness of the increased spending energy in two different population of patients with breast cancer by using the questionnaire POPAQ (Population Physical Activity Questionnaire). This is a prospective study including two groups of 15 consecutive breast cancer patients (≤ 50 years Group 1 and Group 2 > 50 and < 70 years) followed in the department of radiotherapy at the Institute of Cancer of the Loire from January to July 2011. A questionnaire of physical activity assessment was used at two different times before the diagnosis/treatment of breast cancer (t0) and at 6 months (t6) to measure the impact of the awareness method. Comparison of different measures of daily energy expenditure (t0) between groups 1 and 2 was statistically significant (1,1803 and 9434 kJ/24 h, respectively, p = 0.0005). Daily energy expenditure of professional activity was statistically different between the two groups (1437 and 457 kJ/24 h, in groups 1 and 2, respectively; p = 0.003). Between t0 and t6, we observed a significant decrease in total energy consumption in group 1 (1,1803 to 1,0876 kJ/24 h) while there was no significant change between the group 2, except energy expended at rest (basal metabolism). There were differences in daily energy expenditure based on age may influence behavioral patterns deal with energy expenditure in physical activities. Tomorrow's challenges are to provide re-entrainment programs tailored to targeted populations.

[Axillary lymph node irradiation in breast cancer: state of the art]. / Radiothérapie du creux axillaire dans les cancers du sein : état des lieux.

Place of axillary radiotherapy in the management of patients with breast cancer remains debated. While the prognostic value of axillary lymph node extension has been largely demonstrated, the benefit of axillary treatment is more uncertain. Large clinical trials having demonstrated the benefit of adjuvant radiotherapy in advanced breast cancer comprised large nodal irradiation, including axillary area. Analyzing the true benefit of axillary radiotherapy is rendered difficult by heterogeneity of series, particularly when focusing on the extent of lymph node dissection. Although adjuvant axillary radiotherapy is usually recommended in patients with insufficient lymph node dissection or with bulky axillary involvement, the prognosis in these patients remains poor by metastatic evolution and such strategy exposes to increased toxicity and functional sequels. Further assessments should better define the optimal indications and the true benefit of axillary radiotherapy.

Prolonged temozolomide for treatment of glioblastoma: preliminary clinical results and prognostic value of p53 overexpression.

We report retrospective data on the feasibility and efficacy of prolonging adjuvant temozolomide (TMZ) more than 6 months after chemoradiotherapy completion in patients with glioblastoma (GBM). Molecular prognostic factors were assessed. Data from 46 patients were reviewed. Patients received postoperative irradiation, 60 Gy in 30 fractions, combined with concurrent TMZ, 75 mg/m(2). Four weeks later, adjuvant TMZ was prescribed, 150-200 mg/m(2) for a total of 24 cycles unless there was progression or toxicity. Tumor samples were tested for the following prognostic factors: EGFR overexpression, 1p19q deletion, p53 overexpression and proliferation index. Overall survival (OS) was 84.8% at 6 months, 54.3% at 12 months, 26.1% at 18 months, and 21.7% at 24 months. Progression-free survival (PFS) was 73.9% at 6 months, 34.8% at 12 months, 15.2% at 18 months and 10.4% at 24 months. In the adjuvant phase, no treatment disruption for toxicity was necessary but eight patients required dose adaptation because of side effects. No significant molecular prognostic factor was evidenced for OS. We found that p53 overexpression was the only significant prognostic factor for PFS, with a median PFS of 9.3 months versus 7 months for patients without p53 overexpression (P = 0.031). This study suggests that delivering adjuvant TMZ therapy for more than 6 months is feasible in patients with GBM. Efficacy data warrant further prospective assessment with the focus on molecular prognostic factors, such as p53 overexpression, which was found to be the only significant molecular prognostic factor for outcome.