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In 1998, an editorial from the International Journal of Radiation Oncology - Biology - Physics (IJROBP) on the occasion of the publication of Phase I by Zelefsky et al. on 3D radiotherapy dose escalation asked the question: "will more prove better?". More than 20 years later, several prospective studies have supported the authors' conclusions, making dose escalation a new standard in prostate cancer. The data from prospective randomized studies were ultimately disappointing in that they failed to show an overall survival benefit from dose escalation. However, there is a clear and consistent benefit in biochemical recurrence-free survival, which must be weighed on an individual patient basis against the potential additional toxicity of dose escalation. Techniques and concepts have become more and more precise, such as intensity modulated irradiation, simultaneous integrated boost, hypofractionated dose-escalation, pelvic irradiation with involved node boost or focal dose-escalation on gross recurrence after prostatectomy. The objective here was to summarize the prospective data on dose escalation in prostate cancer and in particular on recent advances in the field. In 2022, can we finally say that more has proven better?

Because of the physical properties of proton beam radiation therapy (PT), which allows energy to be deposited at a specific depth with a rapid energy fall-off beyond that depth, PT has several theoretical advantages over photon radiation therapy for esophageal cancer (EC). Protons have the potential to reduce the dose to healthy tissue and to more safely allow treatment of tumors near critical organs, dose escalation, trimodal treatment, and re-irradiation. In recent years, larger multicenter retrospective studies have been published showing excellent survival rates, lower than expected toxicities and even better outcomes with PT than with photon radiotherapy even using IMRT or VMAT techniques. Although PT was associated with reduced toxicities, postoperative complications, and hospital stays compared to photon radiation therapy, these studies all had inherent biases in relation with patient selection for PT. These observations were recently confirmed by a randomized phase II study in locally advanced EC that showed significantly reduced toxicities with protons compared with IMRT. Currently, two randomized phase III trials (NRG-GI006 in the US and PROTECT in Europe) are being conducted to confirm whether protons could become the standard of care in locally advanced and resectable esophageal cancers.

Purpose This study aimed to assess the risk of acute and late radiation-induced toxicity in patients with COVID-19. Material and methods All the patients irradiated in Institut Curie from March to July 2020 were included if the first symptoms related to COVID-19 occurred no more than two months before the start of radiation therapy (RT) or 15 days after the end of RT. Results Twenty-nine patients were included in this analysis. Twenty-five patients had no co-morbidities (86.2%), including morbid obesity. The diagnosis of COVID-19 infection was based on a positive SARS-CoV-2 RNA test for 18 patients (62.1%), a positive serology test for three patients (10.3%), and/or radiologic findings for 12 patients (41.4%). Three patients with symptoms highly suggestive of COVID-19 were included, although they had negative biologic tests and did not have a chest CT scan. Median time from the diagnosis of COVID-19 to the onset of RT was 5.5 days. Modification of RT course due to COVID-19 status was observed in 15 patients, including four for whom RT was definitively stopped. Six patients needed hospitalization for hypoxemic lung disease requiring intensive care. The majority of patients did not experience severe (> grade 2) acute toxicity. After a median follow-up of 6 months (IQR, 1 - 9 months), none of the patients had unusual clinical or radiological late toxicities. Conclusion The observed acute and late toxicities were ultimately similar to those observed in a population not infected with COVID-19. These results do not prompt modification of standard RT protocols for irradiation of COVID-19 patients.

Highlights • During COVID-19 lockdown, the number of radiotherapy treatments had to be reduced. • Given number of delayed treatments, the post-crisis period should be anticipated. • Data visualization software allowed to predict when peak activity would happen.

Background: Palbociclib, a small-molecule inhibitor of cyclin-dependent kinases (CDK4 and CDK6), combined with letrozole increases progression-free survival among patients with previously untreated ER-positive, HER2 negative advanced breast cancer. However, the data on the safety of the concomitant association between Palbociclib and radiation therapy are scarce. The purpose of our study was to retrospectively evaluate the tolerance of the first patients treated with this concomitant combination at Institut Curie. Materials and methods: Between April 2017 and July 2019, 27 women with ER-positive, HER2 negative metastatic breast cancer received locoregional and/or symptomatic irradiation at a metastatic site concomitantly with Palbociclib at a daily dose of 125 mg, from d1 to d21 every 28 days. Palbociclib was always associated with an endocrine treatment: Letrozole (17 patients /27, with or without an LHRH analogue) or Fulvestrant (10 patients /27). Median age at the time of diagnosis of metastases was 60 years (range, 35-85 years). Thirty-two sites were irradiated: 9 patients received post-operative locoregional radiation therapy, including the chest wall or breast and lymph node areas, and 23 sites of metastases were irradiated: 15 at the spine (3 cervical, 6 thoracic, 4 lumbar, 2 sacral), 2 pelvic lesions, 4 peripheral skeletal lesions, 1 brain lesion and 1 choroidal lesion (two patients received locoregional treatment and irradiation in one metastatic site and two patients were treated in two different metastatic sites). The dose prescribed for locoregional mammary radiotherapy was 50 Gy in 25 fractions and varied for the treatment of metastatic sites: 20 Gy in 5 fractions (n=14), 30 Gy in 10 fractions (n=7) and 8 Gy in 1 fraction (n=1). The brain metastasis was stereotactically treated (1 fraction of 18 Gy). The primary endpoint was toxicity scored according to the common terminology criteria for NCI adverse events, version v4.0. Results: Median follow-up was 22 months (range, 4 to 54). Mean number of days of Palbociclib during radiation therapy was 8.7 days (range, 1 to 23 days). Most common acute toxicities were radiodermatitis (12/27, including 1 grade 3, 2 grade 2 and 9 grade 1) and neutropenia (13/27, including 1 grade 4, 7 grade 3, 5 grade 2). Palbociclib had to be stopped during the radiation therapy of three patients (3/27): one patient treated locoregionally (bilateral breast and lymph nodes irradiation) developed a grade 3 radiodermatitis and febrile neutropenia, another treated locoregionally developed grade 2 dysphagia (loss of 4 kg in 1 month) and one patient treated for sacral metastases (20 Gy in 4 fractions) developed grade 3 proctitis. Of the 19/27 patients with a follow-up of more than 6 months none developed late toxicities. Conclusion: Concomitant administration of Palbociclib with radiation therapy was reasonably well tolerated in our series of 27 patients. Caution should be exercised when a large volume is irradiated, and when the dose per fraction is high. It remains unsure whether the interruption-causing side effects of Palbociclib was based on synergistic toxicity with radiation therapy. We suggest that our findings are to be confirmed in prospective registration studies collecting larger number of patients. Citation Format: Arnaud Beddok, Alexandre Arsene-Henry, Baptiste Porte, Kim Cao, Louis Bazire, Nathaniel Scher, Alain Labib, Ilan Darmon, Joëlle Otz, Mathieu Minsat, Hamid Mammar, François Clément Bidar, Alain Fourquet, Paul Cottu, Phlip Poortmans, Youlia Kirova. A retrospective study of 27 patients with ER-positive, HER2 negative metastatic breast cancer treated with concomitant palbociclib and radiation therapy [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P4-12-05.

Because of the physical properties of proton beam radiation therapy (PT), which allows energy to be deposited at a specific depth with a rapid energy fall-off beyond that depth, PT has several theoretical advantages over photon radiation therapy for esophageal cancer (EC). Protons have the potential to reduce the dose to healthy tissue and to more safely allow treatment of tumors near critical organs, dose escalation, trimodal treatment, and re-irradiation. In recent years, larger multicenter retrospective studies have been published showing excellent survival rates, lower than expected toxicities and even better outcomes with PT than with photon radiotherapy even using IMRT or VMAT techniques. Although PT was associated with reduced toxicities, postoperative complications, and hospital stays compared to photon radiation therapy, these studies all had inherent biases in relation with patient selection for PT. These observations were recently confirmed by a randomized phase II study in locally advanced EC that showed significantly reduced toxicities with protons compared with IMRT. Currently, two randomized phase III trials (NRG-GI006 in the US and PROTECT in Europe) are being conducted to confirm whether protons could become the standard of care in locally advanced and resectable esophageal cancers.

Purpose To evaluate the association between dynamic contrast material-enhanced (DCE) and diffusion-weighted (DW) magnetic resonance (MR) imaging with pathologic complete response after preoperative combined chemotherapy and radiation therapy for cervical carcinoma and evaluate the risk of local recurrence. Materials and Methods The institutional ethics committee approved the study and waived the requirement to obtain informed consent. The study comprised 52 patients with locally advanced carcinoma, treated first with combined chemotherapy and radiation therapy, who underwent MR imaging before final surgery between June 2011 and July 2015. Three radiologists evaluated conventional, DW, and DCE MR images to identify a complete response. The standard of reference was surgical-pathologic findings. Results An initial increase in signal intensity on DCE MR images that was greater in the cervical lesion than in the myometrium was defined as time-signal intensity curve type B and showed a significant association with incomplete response (P = .0004). DCE MR imaging parameters (ie, maximum slope enhancement, area under the gadolinium concentration-time curve during the first 90 seconds after gadolinium injection [AUGC90], and volume transfer constant [Ktrans]) and a low signal intensity on apparent diffusion coefficient (ADC) maps were significantly associated with an incomplete response (P = .027, P = .041, P = .037, and P = .032, respectively). A mean ADC of 0.0014 m2/sec or less (hazard ratio [HR] = 8.3), low ADC signal intensity (HR = 7.3), high signal intensity at DW imaging (HR = 7.1), and time-signal intensity curve type B (HR = 4.3) were associated with earlier recurrence (P 0.9) and the following parameters: AUGC90, Ktrans, and maximum slope enhancement (intraclass correlation coefficient, >0.9). Conclusion DCE MR imaging parameters, especially the time-signal intensity curve, and DW imaging are associated with complete response and incomplete response and could potentially help oncologists with management decisions. Moreover, DCE and DW MR imaging could help oncologists accentuate the follow-up for patients with a high risk of local recurrence to assess for recurrence. © RSNA, 2017 Online supplemental material is available for this article.

International audience; Purpose: To analyze the clinical outcomes and the safety of radiochemotherapy (RCT) and image-guided adaptive brachytherapy (IGABT) and to evaluate the impact of hysterectomy (HT) as completion of treatment for cervical cancer.Methods and materials: 145 patients with locally advanced cervical cancer were treated at our institution. Patients underwent RCT and IGABT, then hysterectomy (HT) as completion of treatment was performed, with the exception of patients with surgical contraindications, para aortic metastatic disease or patients who refused surgery. Clinical outcomes and morbidity were retrospectively reviewed in both groups. Local relapse free survival (LRFS), pelvic relapse free survival (PRFS) and overall survival (OS) were analyzed.Results: Completion HT was performed in 90 (62.1%) patients. Complete histological response and microscopic disease were found in 77 patients (85.6%). Local relapse was observed in 14 patients (9.6%) without differences between completion HT group and the definitive RCT and IGABT group (Odds Ratio OR = 1.73 [0.57-5.23], p = 0.33). The estimated 3-year LRFS and PRFS for the entire population were respectively 90% [84%-94%] and 93% [87%-96%], with no significant differences between them (respectively Hazard Ratio HR = 0.57 [0.20-1.64], p = 0.30 and HR = 0.37 [0.10-1.31], p = 0.12). The estimated 3-year OS rate for the whole population was 84% [75%-91%] with no significant differences between groups (HR = 0.81 [0.32-2.06], p = 0.65). Regarding morbidity, grade ≥ 2 vaginal toxicity was more frequent in the definitive RCT and IGABT group (43.6% vs 26.7%, p = 0.04). All grade 4 toxicity events were reported in the completion HT group.Conclusions: Due to high severe toxicity, RCT and IGABT with dose escalation followed by completion hysterectomy don't seem compatible. No benefit and increased severe late morbidity were observed. Combined intracavitary/interstitial technique is mandatory in large target volume at brachytherapy.

Purpose The purpose of this study was to analyze and compare clinical outcomes of low-dose-rate (LDR) and high-dose-rate (HDR) interstitial brachytherapy boost (ISBT) after EBRT or radio chemotherapy for the treatment of anal canal cancers. Methods and Materials One hundred patients with anal canal cancers were treated at our institution by ISBT [LDR (n = 50); HDR (n = 50)]. Chronic toxicity rates, local control, disease-free survival, overall survival, and colostomy-free survival of the two different dose-rate brachytherapy modalities were analyzed and compared. Results With a median followup of 42.2 months (95% CI, [34.5–48.8]), 9 (9% [4.8–16.2%]) local recurrences were observed, 4 (8% [3.2–18.8%]) in LDR vs. 5 (10% [4.4–21.4%]) in HDR group (odds ratio [OR] = 1.28 [0.32–5.07], p = 0.73). The 5-year rate of local control for the entire population was 90% [81–95%], 93% [79–98%] vs. 86% [69–94%] for LDR and HDR, respectively (p = 0.38). The 5-year disease-free survival rate for all patients was 82% [71–90%], 88% [73–95%] vs. 72% [44–88%] for LDR and HDR, respectively (p = 0.21). The 5-year overall survival rate for global population was 94% [84–98%], with no significant differences between LDR (97% [79–100%]) and HDR (93% [80–98%]) (p = 0.27). The 5-year colostomy-free survival rate was 92% [83–96%], respectively, 95% [83–99%] vs. 86% [69–94%] for LDR and HDR (p = 0.21). Significant differences were found in terms of chronic toxicity rates, with 28 (56% [42.3–68.8%]) patients concerned in low-dose-rate brachytherapy vs. 17 (34% [22.4–47.9%]) in high-dose-rate brachytherapy (OR = 0.40 [0.18–0.91], p = 0.03). Conclusions Local recurrence rates were comparable between both groups; HDR brachytherapy seem to have a better toxicity profile. Our data confirmed the finding that HDR can be used to safely administer ISBT without increasing chronic toxicity.

Resume Il existe de nombreuses options de traitement pour les cancers de prostate localises, incluant la surveillance active, la curietherapie, la radiotherapie externe et la prostatectomie radicale. La qualite de vie reste un objectif primordial en l’absence de superiorite d’une strategie par rapport a une autre en termes de survie specifique avec des taux de controles biochimiques a long terme equivalents. Malgre une diminution significative de la toxicite digestive et urinaire grâce a la RCMI guidee par l’image, la radiotherapie externe reste un traitement etale sur environ deux mois ou 1,5 mois, en association avec la curietherapie. Compte tenu d’une radiosensibilite differente de cette tumeur, plusieurs etudes randomisees ont montre qu’un traitement hypofractionne est non inferieur en termes de controle biochimique et de toxicite, permettant de diviser le nombre de seances par un facteur 2 a 8. Bien que reserve encore a une population de patients selectionnes presentant un cancer de prostate localise, l’hypofractionnement extreme devient un vrai competiteur de la radiotherapie externe classique ou de la curietherapie.

There are many treatment options for localized prostate cancers, including active surveillance, brachytherapy, external beam radiotherapy, and radical prostatectomy. Quality of life remains a primary objective in the absence of superiority of one strategy over another in terms of specific survival with similar long-term biochemical control rates. Despite a significant decrease in digestive and urinary toxicities thanks to IMRT and IGRT, external radiotherapy remains a treatment that lasts approximately 2 months or 1.5 months, when combined with a brachytherapy boost. Given the specific radiosensitivity of this tumor, several randomized studies have shown that a hypofractionated scheme is not inferior in terms of biochemical control and toxicities, allowing to divide the number of fractions by a factor 2 to 8. Given that SBRT becomes a validated therapeutic option for a selected population of patients with localized prostate cancer, extreme hypofractionation is becoming a strong challenger of conventional external radiotherapy or brachytherapy.

Background Chemoradiotherapy (CRT) is the standard of care for patients diagnosed with locally advanced cervical cancer (LACC), a human papillomavirus (HPV)-related cancer that relapses in 30%-60% of patients. This study aimed to (i) design HPV droplet digital PCR (ddPCR) assays for blood detection (including rare genotypes) and (ii) monitor blood HPV circulating tumor DNA (HPV ctDNA) levels during CRT in patients with LACC. Methods We analyzed blood and tumor samples from 55 patients with HPV-positive LACC treated by CRT in a retrospective cohort (n = 41) and a prospective cohort (n = 14). HPV-ctDNA detection was carried out by genotype-specific ddPCR. Results HPV ctDNA was successfully detected in 69% of patients (n = 38/55) before CRT for LACC, including nine patients with a rare genotype. HPV-ctDNA level was correlated with HPV copy number in the tumor (r = 0.41, P < 0.001). HPV-ctDNA positivity for HPV18 (20%, n = 2/10) was significantly lower than for HPV16 (77%, n = 27/35) or other types (90%, n = 9/10, P = 0.002). HPV-ctDNA detection (positive versus negative) before CRT was associated with tumor stage (P = 0.037) and lymph node status (P = 0.02). Taking into account all samples from the end of CRT and during follow-up in the prospective cohort, positive HPV-ctDNA detection was associated with lower disease-free survival (DFS) (P = 0.048) and overall survival (OS) (P = 0.0013). Conclusion This is one of the largest studies to report HPV-ctDNA detection before CRT and showed clearance of HPV ctDNA at the end of treatment in most patients. Residual HPV ctDNA at the end of CRT or during follow-up could help to identify patients more likely to experience subsequent relapse., Highlights • HPV ctDNA can be detected before CRT in patients with LACC (69%). • HPV-ctDNA detection was associated with tumor stage and lymph node status. • A lower detection rate of HPV ctDNA was observed for HPV18 genotype. • Residual ctDNA levels after CRT and during follow-up had a prognostic impact.

e12598 Background: Palbociclib, a small-molecule inhibitor of cyclin-dependent kinases (CDK4 and CDK6), combined with letrozole increases progression-free survival among patients with previously untreated ER-positive, HER2 negative advanced breast cancer. The purpose of our study was to retrospectively evaluate the tolerance of the concomitant association of Palbociclib and radiation therapy (RT) at Curie Institute. Methods: Between April 2017 and August 2019, 30 women with ER-positive, HER2 negative metastatic breast cancer received locoregional (LR) and/or symptomatic irradiation at a metastatic site concurrently with Palbociclib at a daily dose of 125 mg, from d1 to d21 every 28 days. Palbociclib was always associated with endocrine therapy: letrozole (with or without an LHRH analogue) or fulvestrant. Thirty-five sites were irradiated: nine patients received post-operative locoregional RT, including the chest wall or breast and lymph node areas, and 26 sites of metastases were irradiated: 17 at the spine, 7 peripheral skeletal lesions, 1 brain lesion and 1 choroidal lesion. The dose prescribed for locoregional mammary radiotherapy was 50 Gy in 25 fractions and varied for the treatment of metastatic sites: 20 Gy in 5 fractions (n = 13), 30 Gy in 10 fractions (n = 10) and 8 Gy in 1 fraction (n = 2). The brain metastasis was stereotactically treated (1 fraction of 18 Gy). The primary endpoint was toxicity scored according to the common terminology criteria for NCI adverse events, version v5.0. Results: Mean number of days of Palbociclib during RT was 8.8 days (range, 1 to 24 days). The most common acute toxicities were dermatitis (12/35, including 2 grade 2) and neutropenia (12/35, including 9 grade 2). Palbociclib had to be stopped during the RT of two patients (2/30): one patient treated locoregionally (bilateral breast and lymph nodes irradiation) developed a grade 3 dermatitis and febrile neutropenia, another treated locoregionally developed grade 2 dysphagia. After a median follow-up since the end of RT of 17 months (6 – 31 months, SD 8), none of the patients have so far exhibited late toxicity. Conclusions: Concomitant administration of palbociclib with RT was reasonably well tolerated in our series of 30 patients. Given this experience, palbociclib should not be discontinued during radiation therapy. Nevertheless, our findings should be confirmed in prospective registration studies collecting larger number of patients.

Objectifs La radiotherapie hypofractionnee a montre son equivalence en termes d’efficacite dans plusieurs essais randomises avec des profils de toxicite differents. Elle n’est pas encore un standard en France. L’objectif de l’etude est d’evaluer la tolerance en cours de radiotherapie et a 4–6 mois sur une serie de patients traites pour un adenocarcinome prostatique en radiotherapie moderement hypofractionnee avec escalade de dose. Methodes Au total, 212 patients ont ete traites consecutivement entre fevrier 2016 et mars 2018. La dose delivree etait de 75 gy en 30 fractions au niveau de la prostate et des vs proximales (eqd2 = 82,5 a 85,7 gy en fractions de 2 gy pour un α/β de 1,5 a 3). Cent quatre-vingt-quinze patients (92 %) ont recu une irradiation ganglionnaire pelvienne (46 gy en 23 fractions). La technique d’irradiation a ete une rcmi rotationnelle (Rapidarc®) guidee par l’image apres implantation de 3 grains d’or intraprostatiques. Les toxicites urinaires et digestives ont ete recueillies en cours de radiotherapie et a 4–6 mois. Des facteurs predictifs de toxicite ont ete recherches. Resultats Les caracteristiques des patients etaient : âge median = 71 ans [46–86], psa initial median = 9,46 ng/mL [1,97–652], stade t1, t2, t3, t4 : 32 %, 23 %, 43 % et 2 %. Stade n1 et m1 : 19 et 1 patients. Score de Gleason 6, 7 (3 + 4), 7 (4 + 3) et ≥ 8 dans 19 %, 44 %, 22 % et 15 % des cas. Les toxicites urinaires et digestives de grade 1 ont ete de 50 % et 61 %, celles de grade 2 de 44 % et 2 %. Avec un recul de 4–6 mois apres la fin de la radiotherapie, les toxicites urinaires et digestives de grade 1 ont ete de 52 % et 23 %, de grade 2 de 15 % et 0 %. Une toxicite urinaire grade 3 ( Fig. 1 , Fig. 2 , Fig. 3 ). Conclusion La radiotherapie prostatique moderement hypofractionnee avec escalade de dose est bien toleree. Elle permet de reduire sensiblement le temps de traitement. Ces donnees encourageantes doivent etre confirmees sur le long terme.

Aims To compare survival outcomes after mastectomy (Mt) and lumpectomy plus interstitial brachytherapy (LpIB) in the treatment of breast cancer local recurrence (LR) occurring after conservative surgery. Methods Medical records of patients treated for an isolated LR from January 1, 1981 to December 31, 2009 were reviewed. To overcome the bias due to the fact that treatment choice (Mt or LpIB) was based on prognostic factors with LpIB proposed preferentially to women with good prognosis, Mt and LpIB populations were matched and compared with regard to overall survival (OS) and metastasis free survival (MFS). Results Among 348 patients analyzed, 66.7% underwent Mt, 17.8% LpIB and 15.5% Lp alone. After a median follow-up of 73.3 months, 65 patients had died (42/232 Mt, 8/62 LpIB, 15/54 Lp). Before matching, OS and MFS at 5 years were significantly better in the LpIB compared to the Mt group, due to significantly more frequent poor prognostic factors in the latter (p = 0,07 and p = 0,09 respectively, log-rank significance limit of 10%). After matching, the benefits of LpIB disappeared since MFS and OS rates were not significantly different in both groups (p = 0.68 and 0.88 respectively). After LpIB, the second LR rate was 17% at 5 years and 30% at 10 years. Conclusion A second conservative breast cancer treatment associating lumpectomy and interstitial brachytherapy is possible for selected patients with LR, without decrease in neither OS nor MFS compared to mastectomy.

The advent of sentinel lymph-node technique has led to a shift in lymph-node staging, due to the emergence of new entities namely micrometastases (pN1mi) and isolated tumor cells [pN0(i+)]. The prognostic significance of this low positivity in axillary lymph nodes is currently debated, as is, therefore its management. This article provides updates evidence-based medicine data to take into account for treatment decision-making in this setting, discussing the locoregional treatment in pN0(i+) and pN1mi patients (completion axillary dissection, axillary irradiation with or without regional nodes irradiation, or observation), according to systemic treatment, with the goal to help physicians in their daily practice.

Resume Objectif de l’etude Les carcinomes adenoides kystiques representent 1 % des cancers ORL. Malgre une croissance lente, leur recidive est frequente. La place de la radiotherapie est debattue. Cette etude retrospective multicentrique du cercle des oncologues radiotherapeutes du Sud porte sur 169 patients. Patients et methodes Sur 169 cylindromes ORL inclus entre 1982 et 2010, 135 n’avaient jamais ete traites et 34 etaient en situation de recidive. Le site tumoral etait la parotide pour 48 patients, la glande sous-maxillaire pour 22, les cavites sinusiennes pour 22, le palais pour 21, ailleurs pour 56. Le stade etait T1 pour 12,4 % des patients, T2 pour 14,2 %, T3 pour 12,4 %, T4 pour 41,4 % et Tx pour 19,5 %, 13 % des tumeurs atteignaient les ganglions et 8,9 % etaient metastatiques. Dix-sept cylindromes parotidiens etaient responsables d’une paralysie faciale. Il a ete realise une chirurgie seule pour 27 patients, une chirurgie suivie de radiotherapie pour 89, une chirurgie suivie de chimioradiotherapie pour 12, une chimioradiotherapie exclusive pour 13, une radiotherapie exclusive pour 14, une autre association pour cinq, une abstention pour sept. La radiotherapie a ete delivree 119 fois par photons, six fois par neutrons et quatre fois par photons et neutrons. La dose mediane delivree a la tumeur etait de 65 Gy, et celle aux ganglions de 50 Gy. Resultats Le suivi moyen etait 58 mois. Les probabilites de survie globale et de survie sans maladie etaient respectivement de 72 % et 72 % a cinq ans, 53 % et 32 % a dix ans. Celle de survie sans rechute locale etait de 81 % a cinq ans, 52 % a dix ans. En analyse multifactorielle, la survie sans maladie etait liee a la chirurgie (p Conclusion Dans cette serie de cylindromes ORL localement evolues, recidivants ou metastatiques, la probabilite de survie globale a dix ans etait de plus de 50 %. La radiotherapie n’a pas influe le pronostic.

Objectif de l’etude L’objectif etait l’evaluation de la tolerance urinaire et digestive en cours de radiotherapie et a 4 mois. Materiel et methode Cent dix-huit patients ont ete pris en charge consecutivement entre fevrier 2016 et janvier 2017. La dose totale d’irradiation a ete de 75 Gy en 30 fractions dans la prostate. Cent sept patients (91 %) ont recu une irradiation ganglionnaire pelvienne de 46 Gy en 23 fractions. La technique d’irradiation a ete une radiotherapie conformationnelle avec modulation d’intensite (RCMI) rotationnelle (RapidArc®) guidee par l’image apres implantation de trois grains d’or dans la prostate. Quatre patients ont recu un boost integre dans des adenopathies et quatre une irradiation osseuse (oligometastases). Quatre-vingt-dix-neuf patients ont recu une privation androgenique. Les caracteristiques des patients etaient : l’âge median de 71 ans [51–85 ans], concentration mediane initiale d’antigene specifique de la prostate de 9,23 ng/mL [1,97–304 ng/mL] ; stade : T1, T2, T3, T4 dans respectivement 29 %, 23 %, 45 % et 3 % des cas ; stade N1 : chez dix patients et M1 chez quatre. Score de Gleason 6, 7(3 + 4), 7(4 + 3) et superieur ou egal a 8 dans respectivement 19 %, 48 %, 19 % et 13 % des cas. La toxicite urinaire et digestive a ete recueillie retrospectivement. Des facteurs predictifs de toxicite ont ete recherches. Resultats L’etalement median a ete de 49 jours [42–85 j], sans interruption en rapport avec la toxicite. Une toxicite urinaire de grade 1 ete observee chez 50 % des patients et une toxicite digestive chez 79 %, une de grade 2 chez 42 % et 3 %. Chez 80 patients avec un recul de 4 mois apres la fin de la radiotherapie, une toxicite urinaire de grade 1 a ete observee chez 44 % et une toxicite digestive de 33 %, une de grade 2 de 11 % et 0 %. Aucune toxicite de grade 3 n’a ete observee. Aucune correlation n’a ete retrouvee entre la survenue de cette toxicite et les differents parametres analyses. Conclusion Une radiotherapie prostatique moderement hypofractionnee avec escalade de dose a ete bien toleree. Elle a permis de reduire sensiblement la duree du traitement. Ces donnees encourageantes doivent etre confirmees sur le long terme.

Objectives: Mastectomy (Mt) is considered standard treatment for isolated local recurrence (LR) of breast carcinoma. The aim of our study was to evaluate a second conservative treatment (defined as lumpectomy followed by interstitial brachytherapy (LpIB)) and to determine if it compares favorably with the current standard treatment. Materials and methods: Between January 1981 and December 2009, 348 patients were treated to the Paoli Calmettes Institute (IPC) for an isolated LR: 232 (66,7 %) underwent Mt, 62 (17,8 %) received a second radio-surgical conservative treatment (LpIB) and 54 (15,5 %) a 2nd single surgical treatment (Lp). We classified each population according to the well known prognosis factors. Then, populations Mt and LpIB were matched taking into account these criteria to compare the overall survival (OS), metastasis free survival (MFS) and 2nd local recurrence free survival according to the treatment delivered. Results: On 348 reviewed patients, with a median follow-up of 73,3 months, 65 patients died (42/232 Mt, 8/62 TecCur, 15/54 Tec) and 100 presented metastasis (64/232 Mt, 15/62 TecCur, 21/54 Tec). There was no difference in MFS for the 2 groups, LpIB and Mt (80 % at 5 years) and the OS was non significantly better in the group LpIB compared to the group Mt (90 % and 82 % at 5 years respectively, p=0,28), whereas in the LpIB group 17% and 30% presented a relapse at 5 years and 10 years respectively. They subsequently underwent a salvage mastectomy. Worse results were obtained with lumpectomy alone (OS = 72 % and MFS = 68 % at 5 years) compared with 2 other option treatments. Conclusion: A second conservative treatment for breast cancer recurrence, i.e. lumpectomy and interstitial brachytherapy, is possible for selected patients, without any negative impact on overall survival, nor metastasis free survival. Keywords: Local recurrence, interstitial brachytherapy, lumpectomy, conservative treatment, mastectomy, overall survival, metastasis free survival, breast carcinoma. Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr P3-12-05.

Background This study retrospectively describes the outcome of a series of 38 patients (pts) with T4 anal carcinoma exclusively treated by radio and chemotherapy. Patients and Methods From 1992 to 2007, 38 pts with UST4-N0-2-M0 anal carcinoma were treated with exclusive radiotherapy and chemotherapy. All patients received external beam radiotherapy (EBRT) (median dose 45 Gy) with a concomitant chemotherapy (5-fluorouracil-cisplatin). Eleven patients received neo-adjuvant chemotherapy (5-fluorouracil-cisplatin). After 2–8 weeks, a 15–20 Gy boost was delivered either with EBRT (20 pts) or interstitial 192Ir brachytherapy (18 pts). Mean follow-up was 66 months. Results After chemoradiation therapy (CRT), 13 pts (34%) had a complete response, 23 pts (60%) a response >50% (2 pts were not evaluated). The 5-year-disease-free survival was 79.2 ± 6.5%, and the 5-year overall survival was 83.9 ± 6%. Eight patients developed tumor progression (mean delay 8.8 months), six of them requiring a salvage surgery with definitive colostomy for local relapse. Late severe complication requiring colostomy was observed in 2 pts. The 5-year-colostomy-free survival was 78 ± 6.9%. Patients who received primary chemotherapy had a statistically significant better 5-year colostomy-free survival (100% vs. 38 ± 16.4%, P = 0.0006). Conclusion T4 anal carcinoma can be treated with a curative intent using a sphincter-sparing approach of CRT, and neo-adjuvant chemotherapy should be considered prior to radiotherapy. J. Surg. Oncol. 2011;104:66–71. © 2011 Wiley-Liss, Inc.

Objectif de l’etude En cours d’irradiation mammaire, une surveillance hebdomadaire est habituelle. Celle-ci est consommatrice de temps et de moyens medicotechniques, alors que la toxicite attendue est moderee. L’objectif de cette etude prospective monocentrique est d’evaluer la faisabilite d’une diminution du rythme des consultations de surveillance durant une irradiation mammaire. Materiel et methode A partir du 1er decembre 2017, le rythme de consultation des patientes debutant une irradiation mammaire normofractionnee a ete espacee aux deuxieme et cinquieme semaines de traitement. Si besoin, elles pouvaient demander une consultation non programmee avec le medecin d’astreinte. Le critere d’evaluation principal etait le nombre de patients ayant eu au moins une consultation non programmee. Les criteres d’evaluation secondaires etaient le motif principal de la consultation, le nombre de radiodermites de grade > 2 et la recherche de facteur predictif. Resultats Entre le 1er decembre 2017 et le 30 janvier 2018, 127 patientes ont recu une irradiation mammaire dans notre centre. Trente-trois (26 %) ont eu au moins une consultation non programmee durant leur traitement et huit (6,3 %) en ont eu plus d’une, soit au total 43 consultations non programmees. Une irradiation ganglionnaire etait associee a l’irradiation mammaire ou parietale dans 20,9 % des cas. Le motif principal de la consultation etait majoritairement un probleme cutane (83,7 %) avec une radiodermite de grade 3 dans 16,3 % des cas. La dose moyenne recue etait 43,8 Gy [2,2–65 Gy]. Plus de la moitie des patientes (55,9 %) avait une taille de soutien-gorge superieure a un bonnet B. Conclusion En cours d’irradiation mammaire, une consultation de surveillance aux deuxieme et cinquieme semaines de traitements parait realisable mais non optimale. Plus d’un quart des patientes a eu recours a une consultation non programmee, principalement a la quatrieme semaine et pour toxicite cutanee. Un rythme de consultation toutes les deux semaines de traitement semble plus approprie, avec maintien des consultations non programmees a la demande.

3565Background: Chemoradiotherapy (CRT) is the current standard of care for patients diagnosed with locally advanced anal squamous cell carcinoma (ASCC), but some patients will present a local and/...

International audience; Background: Two options are possible for the management of early stage cervical cancer, without lymph node involvement: radical surgery or brachytherapy followed by surgery. The aim of this study was to compare overall survival (OS) and disease-free survival (DFS) of early stage cervical cancers managed by uterovaginale brachytherapy followed by extrafasciale hysterectomy (group 1) or by radical hysterectomy alone (group 2). The secondary objectives were to compare the morbidity of these two different approaches and to evaluate the parametrial involvement rate in patients managed by radical hysterectomy.Materials and methods: It is a retrospective and collaborative study between the Paoli Calmettes Institute (Marseille) and the Oscar Lambret Center (Lille) from 2001 to 2013, in patients with tumors FIGO stages IA1, IA2, IB1 and IIA less than 2 cm of diameter, without pelvic lymph node involvement.Results: One hundred and fifty-one patients were included (74 in group 1 and 77 in group 2). The demographic characteristics of the two groups were comparable. OS and DFS were respectively 92.3% versus 100% (p = 0.046) and 92.3% and 98.7% (p = 0.18). Complication rates were 12.2% and 44.2%, respectively (p < 0.0001). In group 2, the parametrial invasion rate in this study was 1.30%.Conclusion: In our study, the two strategies are comparable in terms of DFS. Complications seem more frequent in the group 2, but more severe in the group 1. Finally, the low rate of parametrial invasion in group 2 confirms the interest of a less radical surgical treatment in these stages with good prognosis.

Aim To describe the presence of atypical calcifications on post-operative mammography after breast-conserving surgery (BCS) and intraoperative radiotherapy (IORT). Materials and methods We retrospectively include all patients followed after BCS and IORT for breast cancer (n = 271). All follow-up mammograms at 6 months after surgery were retrospectively evaluated by two board-certified radiologists. The radiologists had to notify the presence or the absence of atypical calcifications. Results Five patients had on follow-up mammography the presence of atypical calcifications. Two patients had a stereotactic breast biopsy. The pathologic examination showed the presence of small tungsten particles located in the breast parenchyma. Conclusion The presence of atypical calcifications after BCS and IORT, presenting as multiple, scattered, round calcifications, should be rated as BIRADS 2 and do not require biopsy. They corresponded on tungsten deposits.

The authors present an update version of the indications for radiotherapy in the management of benign diseases. This is based on available randomized trials and recent international meetings. Validated indications remain the prevention of resected heterotopic bone ossifications, keloids scars and pterygium and also treatment of arteriovenous malformations; the place of radiotherapy for malignant exophtalmia is more and more restricted. Randomized trials have demonstrated the efficacy of endobrachytherapy in the prevention of restenosis after angioplasty but the use of embedded stent has replaced this indication. Macular degeneration is no more an indication of radiotherapy. Quality requirements for radiotherapy are identical for benign or malignant indications.

We compared two intensity-modulated radiotherapy techniques for left-sided breast treatment, involving lymph node irradiation including the internal mammary chain. Inverse planned arc-therapy (VMAT) was compared with a forward-planned multi-segment technique with a mono-isocenter (MONOISO). Ten files were planned per technique, delivering a 50-Gy dose to the breast and 46.95 Gy to nodes, within 25 fractions. Comparative endpoints were planning target volume (PTV) coverage, dose to surrounding structures, and treatment delivery time. PTV coverage, homogeneity and conformality were better for two arc VMAT plans; V95%(PTV-T) was 96% for VMAT vs 89.2% for MONOISO. Homogeneity index (HI)(PTV-T) was 0.1 and HI(PTV-N) was 0.1 for VMAT vs 0.6 and 0.5 for MONOISO. Treatment delivery time was reduced by a factor of two using VMAT relative to MONOISO (84 s vs 180 s). High doses to organs at risk were reduced (V30(left lung) = 14% using VMAT vs 24.4% with MONOISO; dose to 2% of the volume (D2%)(heart) = 26.1 Gy vs 32 Gy), especially to the left coronary artery (LCA) (D2%(LCA) = 34.4 Gy vs 40.3 Gy). However, VMAT delivered low doses to a larger volume, including contralateral organs (mean dose [Dmean](right lung) = 4 Gy and Dmean(right breast) = 3.2 Gy). These were better protected using MONOISO plans (Dmean(right lung) = 0.8 Gy and Dmean(right breast) = 0.4 Gy). VMAT improved PTV coverage and dose homogeneity, but clinical benefits remain unclear. Decreased dose exposure to the LCA may be clinically relevant. VMAT could be used for complex treatments that are difficult with conventional techniques. Patient age should be considered because of uncertainties concerning secondary malignancies.

Cancer of the anus, vulva, and penis are rare diseases. They are associated with human papillomavirus (HPV) infection. HIV-infected patients have a higher risk of developing these cancers in comparison with the general population. Anal, vulvar, and penile cancers are lymphophilic tumors, and lymph node involvement is the most important predictor of prognosis. Surgery with lymph node dissection is the standard treatment of invasive vulvar and penile cancers. Depending on the surgical pathology result following, adjuvant radiotherapy may be indicated. Radiotherapy with or without concurrent chemotherapy is the standard treatment of anal cancer; salvage abdominoperineal resection is indicated in case of local relapse after radiotherapy.

Objectif de l’etude Estimer les deviations du protocole d’irradiation stereotaxique de l’essai de phase II du groupe d’oncologie radiotherapie tete et cou (Gortec) 2004–2014. Materiel et methodes En raison de l’hypofractionnement, de la diversite et de l’implementation recente de la radiotherapie sterotaxique extracrânienne en France, un cas clinique test a ete soumis aux centres, comme pre-requis aux inclusions. Le cas consistait en deux metastases (de 1,5 et 0,8 cm) du lobe superieur gauche, distantes de 1 cm, a 2 cm des structures mediastinales. Le protocole fournissait des recommandations de dose en trois ou cinq fractions selon le diametre tumoral, le caractere central des metastases (a 2 cm du mediastin) et la distance aux organes a risques critique. Les fichiers digital imaging communication in medicine (DICOMRT) etaient echanges via la plateforme securisee du Gortec. Resultats Parmi 20 centres avec six types d’equipement re radiotherapie sterotaxiques, trois ont implemente la radiotherapie extracrânienne avant 2010. Quatorze centres ont prescrit le tratement en cinq fractions, considerant une lesion centrale. Une scanographier quadridimensionnelle a ete utilisee dans 15 centres. Quatre a 201 faisceaux (non coplanaires, huit cas) ou un demi a trois arcs etaient utilises. Un algorithme de type B etait utilise dans huit cas et la dose adaptee dans un. L’isodose de prescription mediane etait la 80 %. La marge mediane entre le volume tumoral macroscopique (GTV) et le volume ccible antomoclinique (CTV) etait 0 et entre le CTV et le volume cible previsionnel (PTV) de 3 mm. Le diametre maximal du PTV etait de40 mm. Le guidage par l’image etait tridimensionnel dans 12 cas. Les contraintes aux organes a risque etaient respectees. Les indices de conformalite et homogeneite etaient de 1,22 et 1,23 (sous-utilises) ; le R50 (rapport volume de l’isodose 50 %/volume cible previsionnel) et la dose maximale a 2 cm du PTV medians etaient repectivement de 6,6 et 25,5 Gy. Une deviation majeure (delineation du GTV, marges CTV-PTV, prescription) et des deviations mineures ont ete notees dans respectivement cinq et sept centres respectivement. Une autorisation d’inclusion a ete accordee apres correction et reserve dans deux cas. Conclusion Une procedure d’assurance qualite (AQ) realisee a priori sur cas test devrait limiter l’heterogeneite de pratiques et favoriser un meilleur respect du protocole. Une AQ systematique sera realise a posteriori sur criteres juges sensibles pour les cas reels.

La mastectomie totale est le traitement de reference en cas de recidive locale (RL) isolee d’un carcinome mammaire. Notre etude a pour objectif de comparer l’efficacite d’une alternative therapeutique a nouveau conservatrice, associant une nouvelle tumorectomie a de la curietherapie interstitielle (TecCur).

Le but de cette etude etait d’identifier l’impact sur la survie d’un diagnostic precoce de la maladie metastatique par le biais du dosage du CA15-3 dans la surveillance des patientes traitees pour cancer du sein non metastatique.

Adenoid cystic carcinoma represents 1% of head and neck cancers. Adenoid cystic carcinomas are slow growing tumours with high potential for local recurrence. Treatment usually associates radiotherapy and surgery, but the role of radiotherapy remains unclear. We report a retrospective multicentric study of the management and prognostic factors of 169 adenoid cystic carcinomas of head and neck.Between 1982 and 2010, 169 patients with adenoid cystic carcinoma of the head and neck were referred to the Cercle des oncologues radiothérapeutes du Sud departments of radiotherapy either for primary untreated tumour (n=135) or for a recurrence of previously treated tumour (n=34). The site of adenoid cystic carcinoma was: parotid gland (n=48, 28.4%), minor salivary gland (n=35, 20.7%), submandibular gland (n=22, 13%), sinus cavities (n=22, 13%), other (n=42, 24.9%). Tumour stages were: T1 (12.4%); T2 (14.2%); T3 (12.4%); T4 (41.4%) and Tx (19.5%). Lymph node involvement was 13% and distant metastasis 8.9%. For adenoid cystic carcinomas of the parotid gland, major nerve involvement was evaluated. Preferential site of metastasis was the lung (87.5%). Treatments were: surgery alone (n=27), surgery and adjuvant radiotherapy (n=89), surgery and adjuvant chemoradiotherapy (n=12), exclusive chemoradiotherapy (n=13), exclusive radiotherapy (n=14), other associations (n=5) and no treatment (n=7). Radiotherapy was delivered through photons (n=119), neutrons (n=6), both (n=4). Two patients had a brachytherapy boost. Median prescribed doses to T and N were respectively 65 Gy and 50 Gy for the 119 photons treated patients.Mean follow-up was 58 months (range 1-250 months). As of December 1, 2010, 83 patients were alive with no evolutive disease (49%), 35 alive and had recurred, 18 had uncontrolled evolutive disease, 28 had died of adenoid cystic carcinoma and 5 of intercurrent disease. Overall survival and disease free survival were respectively 72% and 72% at 5 years, 53% and 32% at 10 years; 5 and 10-year freedom from local recurrence were 81% and 52% respectively. Nerve involvement was found in 17/48 parotid gland adenoid cystic carcinomas. The Cox model including all patients, showed that surgery (P0.001), surgical margins (P=0.015), nerve involvement (P=0.0079), length of radiotherapy (P=0.018), and tumour location (P=0.041) were associated with disease free survival.In this large series of adenoid cystic carcinoma of head and neck with a majority of T3-T4 tumours, 10-year survivals were achieved for 50% of patients. Radiotherapy did not impact survival.

Purpose To evaluate the benefit of prophylactic inguinal irradiation (PII) in anal canal squamous cell carcinoma (ASCC). Methods and Materials This retrospective study analyzed the outcome of 208 patients presenting with ASCC treated between 2000 and 2004 in four cancer centers of the south of France. Results The population study included 35 T1, 86 T2, 59 T3, 20 T4, and 8 T stage unknown patients. Twenty-seven patients presented with macroscopic inguinal node involvement. Of the 181 patients with uninvolved nodes at presentation, 75 received a PII to a total dose of 45–50 Gy (PII group) and 106 did not receive PII (no PII group). Compared with the no PII group, patients in the PII group were younger (60% vs. 41% of patients age p = 0.01) and had larger tumor (T3-4 = 46% vs. 27% p = 0.01). The other characteristics were well balanced between the two groups. Median follow-up was 61 months. Fourteen patients in the no PII group vs. 1 patient in the PII group developed inguinal recurrence. The 5-year cumulative rate of inguinal recurrence (CRIR) was 2% and 16% in PII and no PII group respectively ( p = 0.006). In the no PII group, the 5-year CRIR was 12% and 30% for T1-T2 and T3-T4 respectively ( p = 0.02). Overall survival, disease-specific survival, and disease-free survival were similar between the two groups. In the PII group, no Grade >2 toxicity of the lower extremity was observed. Conclusion PII with a dose of 45 Gy is safe and highly efficient to prevent inguinal recurrence and should be recommended for all T3-4 tumors. For early-stage tumors, PII should also be discussed, because the 5-year inguinal recurrence risk remains substantial when omitting PII (about 10%).

This study retrospectively describes the outcome of a series of 38 patients (pts) with T4 anal carcinoma exclusively treated by radio and chemotherapy.From 1992 to 2007, 38 pts with UST4-N0-2-M0 anal carcinoma were treated with exclusive radiotherapy and chemotherapy. All patients received external beam radiotherapy (EBRT) (median dose 45 Gy) with a concomitant chemotherapy (5-fluorouracil-cisplatin). Eleven patients received neo-adjuvant chemotherapy (5-fluorouracil-cisplatin). After 2-8 weeks, a 15-20 Gy boost was delivered either with EBRT (20 pts) or interstitial (192)Ir brachytherapy (18 pts). Mean follow-up was 66 months.After chemoradiation therapy (CRT), 13 pts (34%) had a complete response, 23 pts (60%) a response50% (2 pts were not evaluated). The 5-year-disease-free survival was 79.2 ± 6.5%, and the 5-year overall survival was 83.9 ± 6%. Eight patients developed tumor progression (mean delay 8.8 months), six of them requiring a salvage surgery with definitive colostomy for local relapse. Late severe complication requiring colostomy was observed in 2 pts. The 5-year-colostomy-free survival was 78 ± 6.9%. Patients who received primary chemotherapy had a statistically significant better 5-year colostomy-free survival (100% vs. 38 ± 16.4%, P = 0.0006).T4 anal carcinoma can be treated with a curative intent using a sphincter-sparing approach of CRT, and neo-adjuvant chemotherapy should be considered prior to radiotherapy.

The authors present an update version of the indications for radiotherapy in the management of benign diseases. This is based on available randomized trials and recent international meetings. Validated indications remain the prevention of resected heterotopic bone ossifications, keloïds scars and pterygium and also treatment of arteriovenous malformations; the place of radiotherapy for malignant exophtalmia is more and more restricted. Randomized trials have demonstrated the efficacy of endobrachytherapy in the prevention of restenosis after angioplasty but the use of embedded stent has replaced this indication. Macular degeneration is no more an indication of radiotherapy. Quality requirements for radiotherapy are identical for benign or malignant indications.

This paper reports the patient care experience during the course of the radiotherapy. Plights are multiple. Patients are confronted with a complex and unknown distressing space, an irrelavant information, a banalization of side effects, an isolation with a frequent inadequate support of their family or the caregivers team, with the fear of a definitive abandonment at the end of the treatment without comforting follow-up. It is imperative to state a real policy in order to improve the patient support. Sensibilization and training of the caregivers, in spite of a frequent overbooking technical work, is required in a pluridisciplinary approach to provide a relevant reception with the collaboration of psychologists, social workers and self care groups and associations. The personal implication of the physicians and technologists is also essential. The simple smile is the intangible proof of the reliable emotional support.

e15535 Background: Advanced stage cervical cancer (CC) remains a public health issue despite preventive vaccines and screening. EGFR is over-expressed in 50 to 85% of CC and activated in 20%, suggesting that EGFR blockage may be a promising treatment approach. Methods: A randomized phase 2 trial on 78 stage IB2–III patients from 11 French Cancer Centres evaluated the tolerance and early response to cetuximab, an anti EGFR antibody. 40 patients received cetuximab + standard RT and Cisplatinum based chemotherapy (arm A) and 38 patients received standard treatment (B). Primary endpoint is DFS at 2 years and presently not reached. MRI imaging revealed no difference in median (44 vs 40) tumour sizes between arms; there was no difference in age, menopausal status, PI and smoking habits. Parametrial involvement was clinically diagnosed in 19 and 20 cases respectively. Presence of lumbar or para-aortic lymph nodes was an exclusion criterion. Three patients withdrew consent in the cetuximab arm, one accepted standard treatment. Treatment schedules were incomplete in 13 (A) and 14 (B) patients for reasons of haematological or renal toxicity. Results: Surgical resection was feasible in 24 (65%) and 26 (70%) patients in arms A and B respectively.Tolerance was satisfactory in both arms, with significantly more acne form reactions in the cetuximab arm of grade 2 (n= 19) and 3 (n=4). More patients had diarrhea (n=8 vs 4: ns) associated with nausea and vomiting of grade 3 (n=4) and 4 (n=1) in the cetuximab arm (ns).Early results show a complete response at 6 weeks by MRI in 18% and 8% for arms A and B respectively. A central blinded review of the imaging and pathology slides is presently ongoing. Conclusions: The prediction of a response to EGFR targeted therapy in cervical cancer remains a matter of debate since no precise molecular studies are available. Consequently, no decisive results have been achieved in early trials of non selected patients with late stage disease (GOG 76-DD). Biopsy samples are available for the majority of our patients and analyses of EGFR expression, cellular sub-localization and main mutations in the PI3K pathway are ongoing. Molecular studies to allow hierarchical decision making are warranted in future studies.