Simultaneous Radiochemotherapy Research Articles

Cisplatin Versus Carboplatin and Paclitaxel in Radiochemotherapy for Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma.

The implementation of a platinum-containing regimen is recommended for definitive and adjuvant therapy of patients with locally advanced head and neck tumour. We compared the conditions for the use of cisplatin or carboplatin/paclitaxel or for changing between these two regimens on a clinic-specific basis. We evaluated 150 patients with advanced head and neck squamous cell carcinoma who received simultaneous radiochemotherapy at our institution between 2012 and 2017. Chemotherapy with weekly doses of cisplatin (40 mg/m2, group 1) or, in cases of impaired renal and/or cardiac function, with weekly doses of carboplatin AUC2 and paclitaxel (45 mg/m2, group 2), was performed as a first-choice therapy. If toxicities occurred in group 1, treatment was switched to the carboplatin/paclitaxel regimen (group 3). Patient- and therapy-related parameters, toxicity and survival data were compared across groups. We examined 99, 30, and 21 patients in each group who received at least 1 course of chemotherapy. Group 3 patients switched from cisplatin to carboplatin/paclitaxel after a median of 3 courses due to nephrotoxicity (95.2%). The target of at least 5 chemotherapy courses was most frequently achieved by patients in group 1 (69.7%), followed by group 3 (61.9%) and then group 2 (40.0%). Multivariate analysis revealed that patients who switched groups were more likely to be over 60 years old (p=0.021), undergo definitive radiochemotherapy (p=0.049) and develop higher nephrotoxicity (p=0.036) than group 1 patients. Outcomes did not differ between groups. When cisplatin application is contraindicated due to renal- or cardiotoxicity, carboplatin/paclitaxel is an appropriate option.

Prognostic and predictive value of PD-L1 expression and tumour infiltrating lymphocytes (TiLs) in locally advanced NSCLC treated with simultaneous radiochemotherapy in the randomized, multicenter, phase III German Intergroup lung Trial (GILT)

ObjectivesImmune checkpoint inhibition after radiochemotherapy (RTCT) has become a new standard of care for locally advanced non-small cell lung cancer with programmed death-ligand 1 (PD-L1) expression. However, little is known about the prognostic role of immune response markers in this setting. We analysed PD-L1 expression and tumour infiltrating lymphocytes (TiLs) in tumour biopsies from the multicenter German Intergroup Lung Trial (GILT), which previously randomised patients with stage III NSCLC to RTCT with or without consolidation chemotherapy. Materials and methodsWe retrospectively analyzed tumour biopsies from patients treated in the GILT trial. PD-L1 expression was analysed using the Ventana SP263 assay and TiL score (low, intermediate, high) and pattern (excluded, inflamed, desert) were assessed. The primary endpoint of the biomarker analysis was PFS in patients with PD-L1 ≥ 1% vs. PD-L1 < 1% NSCLC. Secondary endpoints explored the prognostic relevance of additional PD-L1 expression levels and TiL score and pattern. ResultsBiopsies were available from 92 patients treated with RTCT. Patients with available tumor tissue did not differ significantly from the whole study population. PD-L1 scores from 78 samples were available for analysis. There was no difference in PFS in the PD-L1 < 1% vs. PD-L1 ≥ 1% subgroups. TiL score was available in 66 patients. Patients with high TiL score showed favourable overall survival compared to the low TiL subgroup. This trend was most pronounced in those patients treated with consolidative chemotherapy. ConclusionIn this analysis, PD-L1 expression did not correlate with PFS following RTCT. However, patients with TiLs > 10% were found to have longer overall survival, especially for those patients treated with consolidation chemotherapy after the end of RTCT. Further analyses to explore the prognostic and predictive relevance of TiLs in the context of consolidative checkpoint inhibition with durvalumab are required.

Cancer of unknown primary (CUP) of the head and neck: retrospective analysis of 81 patients.

The treatment of patients with cervical lymph node metastases without detectable primary tumor remains an important challenge, until today, no standard therapy is available. The present study investigated the multimodal treatment of patients with head and neck CUP syndrome (HNCUP) and their follow-up retrospectively. 81 patients with cervical lymph node metastases without a primary tumor were treated at the Departments of Otorhinolaryngology as well as Radiotherapy and Radiation Oncology at the University of Saarland in Homburg, Germany in the period between 1991 and 2013. All patients received routine work-up consisting of CUP panendoscopy and imaging. Neck dissection was then performed in 77% of the patients. The most common histology was squamous cell carcinoma (80%). Ten percent of the patients had distant metastases. All patients underwent primary or adjuvant radiation therapy, or simultaneous radiochemotherapy. After a median follow-up of 3.5 years, the 5-year survival rate was 30%. There was a local recurrence that was known in 20/63 patients (31%) and distant metastases were documented in 19/61 M0 patients (31%). Higher grade late toxicity (grade 3-4) was observed in 12% of patients. Neck dissection and radiation therapy remains an integral part of HNCUP therapy, while the use of chemotherapy could be considered in selected cases. Prospective multicenter randomized trials would be necessary to identify the best target volume and to clarify the role of chemotherapy.

Current Concepts in the Treatment of Fractures and Tumor-Related Infiltration of the Anterior Skull Base

A total of 196 patients were treated surgically because of complex midfacial, and skull base fractures in the ENT Clinic of University of Lübeck between 2008 and 2012. Diagnosis was performed by computerized tomography. It will be a demonstrated case where the entire skull base was replaced with a titanium mesh. Another aspect represents the tumor-related infiltration of the anterior skull base. Overall 67 patients were treated in the past 7 years due to a malignant tumor of the nose and paranasal sinus system. In addition to rare entities (aesthesioneuroblastome, malignant melanoma, and metastasis of a clear cell Nieren carcinoma) were primarily squamous cell and adenocarcinoma before. Therapeutic surgical resection was performed with the following radiotherapy, brachytherapy, or simultaneous radiochemotherapy in the first place. For very advanced findings such as with intracranial spread, we performed the resection interdisciplinary in collaboration with neurosurgery. The different approaches will be demonstrated.

Craniospinal irradiation with concurrent temozolomide for primary metastatic pediatric high-grade or diffuse intrinsic pontine gliomas

High-grade (HGG) and diffuse intrinsic pontine gliomas (DIPG) with primary metastatic spread are extremely rare and have a dismal prognosis. Analogous to simultaneous radiochemotherapy in non-metastatic HGG and DIPG, concurrent craniospinal irradiation (CSI) and metronomic temozolomide (metroTMZ) may represent a reasonable therapeutic approach. However, the antitumor efficacy and toxicity of this treatment still have to be investigated. Between March 2007 and December 2012, six children with primary metastatic HGG (n = 4) or DIPG (n = 2) received CSI and concurrent metroTMZ based on individual treatment recommendations and, in some cases, within the HIT-HGG2007 multicenter trial. Outcome and treatment-related toxicities were evaluated. All patients received irradiation to the entire craniospinal axis (35.2Gy, n = 5; 36Gy, n = 1:) and 5received a local boost to macroscopic tumor deposits. Simultaneously, metroTMZ (75mg/m(2)/day, n = 5; 60mg/m(2)/day, n = 1) was administered. Additionally, 1patient received nimotuzumab once per week. Within a median follow-up of 10.0months (range 6.5-18.7months), all patients experienced disease progression and 5patients died. Median progression-free survival was 4.0 ± 0.8months (range 2.4-10.7months) and median overall survival was 7.6 ± 3.5months (range 4.0-17.6months). Acute myelosuppression most severely limited application of this aggressive treatment strategy. Severe hematotoxicities (≥ grade3) occurred in all patients and metroTMZ had to be interrupted or discontinued in 4out of 6cases. Concurrent CSI and metroTMZ might represent a feasible treatment approach for primary metastatic HGG and DIPG. On the basis of our experience, severe but manageable acute hematotoxicity has to be expected. An international effort is warranted to reassess the efficacy and toxicity of this approach within a prospective study.

A randomized phase III adjuvant study in high-risk cervical cancer: simultaneous radiochemotherapy with cisplatin (S-RC) versus systemic paclitaxel and carboplatin followed by percutaneous radiation (PC-R): a NOGGO-AGO Intergroup Study

Simultaneous adjuvant platinum-based radiochemotherapy in high-risk cervical cancer (CC) is an established treatment strategy. Sequential paclitaxel (Taxol) and platinum followed by radiotherapy may offer further advantages regarding toxicity. An open-labeled randomized phase III trial was conducted to compare paclitaxel (175 mg/m(2)) plus carboplatin (AUC5) followed by radiation (50.4 Gy) (experimental arm-A) versus simultaneous radiochemotherapy with cisplatin (40 mg/m(2)/week) (arm-B) in patients with stage IB-IIB CC after surgery. Primary objective was progression-free survival (PFS). Overall, 271 patients were randomized and 263 were eligible for evaluation; 132 in arm-A and 131 in arm-B appropriately balanced. The estimated 2-year PFS was 81.8% [95% confidence interval (CI) 74.4-89.1] in arm-B versus 87.2% (95% CI 81.2-93.3) in arm-A (P = 0.235) and the corresponding 5-year survival rates were 85.8% in arm-A and 78.9% in arm-B (P = 0.25). Hematological grade 3/4 toxicity was higher in arm-B. Alopecia (87.9% versus 4.1%; P < 0.001) and neurotoxicity (65.9% versus 15.6%; P < 0.001) were significantly higher in arm-A. Early treatment termination was significantly more frequent in arm-B than in arm-A (32.1% versus 12.9%; P = 0.001). Sequential chemotherapy and radiation in high-risk CC could not show any significant survival benefit; however, a different toxicity profile appeared. This sequential regime may constitute an alternative option when contraindications for immediate postoperative radiation are present.

1529P - Treatment of Patients with Small Cell Lung Cancer in Routine Clinical Practice: 10 Year Trend of Treatment Strategies and Overall Survival

ABSTRACT Introduction Treatment of patients with small cell lung cancer (SCLC) is challenging due to the generally poor prognosis of the disease and the lack of new treatment options. There are few data on how delivered treatment has changed during the past decade in routine clinical practice and how this has effected overall survival. Methods We retrospectively analyzed all patients diagnosed with SCLC at our institution (lung cancer center certified by the German Cancer Society (DKG)) since 2002. Analysis included lines of treatment delivered, progression free survival (PFS) at each therapy line, use of radiotherapy, overall survival (OS), and use of PET-CT. Results Preliminary analysis included 102 patients, of which 41 % had limited disease (LD) and 59 % had extensive disease (ED). For all patients, platinum doublet with etoposide has remained standard first line therapy. For patients with LD, the use of simultaneous thoracic radiochemotherapy replaced sequential chemotherapy followed by thoracic radiotherapy. In order to achieve a smaller radiation field, simultaneous radiochemotherapy was usually preceded by 2 cycles of chemotherapy. For patients with extensive disease, the use of cisplatinum instead of carboplatin increased in good performance status patients due to improved antiemesis (apprepitant). As second line therapy, oral topotecan has largely replaced EpiCO (epirubicin, cyclophosphamide, vincristin). One patient with early recurrence of brain metastasis after radiotherapy and topotecan was treated successfully with oral temozolomide. Since August 2007, all ED patients responding to first line therapy received prophylactic cranial radiation. OS tended to increase throughout the study period (LD: from 14 to 17 months, ED: from 6.7 to 10.1 months). Conclusions New treatment options were successfully implemented in routine clinical practice and resulted in improved survival. However, survival remains unsatisfactory emphasizing the need for early detection and development of additional treatment strategies. Disclosure All authors have declared no conflicts of interest.

Moderne strahlentherapeutische Konzepte - stereotaktisch, adjuvant, palliativ

Radiotherapy is an important and well integrated part in modern treatment concepts for cancer of the lung and pleura. Thanks to technical progress in the last years radiotherapy has managed to prove its role in all stages of lung cancers and has opened a spectrum of new treatment options. Stereotactic radiotherapy of the early NSCLC has become the standard treatment for radically inoperable patients. It provides better local control rates than traditional conventionally fractionated radiotherapy. In stage III NSCLC, simultaneous radiochemotherapy is an effective option with equal results compared to surgery. The standard treatment for limited disease SCLC is primary simultaneous radiochemotherapy. All patients with good response after primary treatment profit from prophylactic cranial irradiation. Adjuvant radiotherapy is a component of the trimodal treatment for curative approaches in patients with pleura mesothelioma. Palliative radiotherapy is the standard treatment for brain metastases, bone metastases and compression or obstruction from thoracal tumour mass.

Radiochemotherapy for lung cancer with cisplatin and vinorelbine orally and shrinking field radiotherapy: Effectivity and feasibility in a nonselected patient collective.

e17516 Background: To explore the side effects and effectivity of simultaneous radiochemotherapy (sim RCT) with cisplatin (Cis-DDP) and vinorelbine orally (VRBo) in pts. with NSCLC. Methods: From 2009 and 2011, a total of 20 pts. (5 female, 15 male) aged between 46 and 82 yrs. with NSCLC stage IIIA/B were irradiated with a median dose of 66.6 Gy to the primary and 45 Gy to the involved nodes as neoadjuvant or palliative treatment. Treatment volumes were adapted to tumor shrinkage after 19.8, 30.6, 45 and 59.4 Gy. Cis-DDP (20 mg/qm d1-4, d29-32) and VRBo (50 mg/qm d1,8,15,22,36,43) were administered simultaneously. Comorbidity was scored by the Charlson Index and nutritional status was monitored. Results: Toxicity rates: thrombopenia 3° 10%, 4° 0%, leucopenia 3° 15%, 4° 20%, haemoglobin 0% 3°/4°, esophagitis 3° 5%, 4° 0%, pneumonitis 3° 0%, 4° 5%. No reduction of planned RT-dose. Chx reduction was done due to hematologic toxicity in 35%. Response rates: CR 10%, PR 75%, SD 10%, PD 5%. 11pts. (55%) are alive after a median FU of 19 months. Conclusions: Sim RCT with Cis-DDP and VRBo results in good tumor response rates and is feasible with acceptable side effects. Shrinking treatment volumes allow adequate dose escalation without the risk for early locoregional recurrence.

Definitive Radiotherapy versus Postoperative Radiotherapy of Patients with Oro- and Hypopharyngeal Cancer: Impact of Prognostic Factors

Purpose. To compare the impact of prognostic factors of patients treated with definitive radio(chemo)therapy versus patients treated with surgery and postoperative radiotherapy for squamous cell carcinoma of the oro- and hypopharynx. Patients and Methods. 162 patients treated with definitive radiotherapy and 126 patients treated with postoperative radiotherapy were retrospectively analysed. The impact of the prognostic factors gender, age, total tumor volume (TTV), pre-radiotherapy hemoglobin level (Hb-level), tumor site, T- and N-classification, radiotherapy interruptions >5 days, radiotherapy versus simultaneous radiochemotherapy, R-status and time interval between surgery and radiotherapy were investigated. Results. The median follow-up time for the censored patients treated with definitive radio(chemo)therapy was 28.5 months and for postoperative radiotherapy 36.5 months. On univariate analysis, the TTV, Hb-level, and simultaneous radiochemotherapy had a significant impact on the survival of patients treated with definitive radio(chemo)therapy. For patients treated with postoperative radiotherapy, only the TTV showed a statistical trend for the survival (P = 0.13). On multivariate analysis, the TTV and simultaneous radiochemotherapy maintained their statistical significance for patients treated with definitive raditherapy, and the TTV, the statistical trend for patients treated with postoperative radiotherapy (P = 0.19). Conclusions. The TTV was the predominant prognostic factor for both, patients treated with definitive or postoperative radiotherapy.

Toxicity after radiochemotherapy for glioblastoma using temozolomide - a retrospective evaluation

PurposeRetrospective evaluation of toxicity and results after radiochemotherapy for glioblastoma.Methods46 patients with histopathologically proven glioblastoma received simultaneous radiochemotherapy (RCT). The mean age at the beginning of therapy was 59 years, the mean Karnofsky performance index 80%. 44 patients had been operated on before radiotherapy, two had not. A total dose of 60 Gy was applied in daily single fractions of 2.0 Gy within six weeks, 75 mg/m2/day Temozolomide were given orally during the whole radiotherapy period.ResultsA local progression could be diagnosed in 34/46 patients (70%). The median survival time amounted to 13.6 months resulting in one-year and two-year survival probabilities of 48% and 8%, respectively.Radiotherapy could be applied completely in 89% of the patients. Chemotherapy could be completed according to schedule only in 56.5%, the main reason being blood toxicity (50% of the interruptions). Most of those patients suffered from leucopenia and/or thrombopenia grade III and IV CTC (Common toxicity criteria). Further reasons were an unfavourable general health status or a rise of liver enzymes.The mean duration of thrombopenia and leucopenia amounted to 64 and 20 days. In two patients, blood cell counts remained abnormal until death. In two patients we noticed a rise of liver enzymes. In one of these in the healing phase of hepatitis a rise of ASAT and ALAT CTC grade IV was diagnosed. These values normalized after termination of temozolomide medication. One patient died of pneumonia during therapy.ConclusionOur survival data were well within the range taken from the literature. However, we noticed a considerable frequency and intensity of side effects to bone marrow and liver. These lead to the recommendations that regular examinations of blood cell count and liver enzymes should be performed during therapy and temozolomide should not be applied or application should be terminated according to the criteria given by the manufacturer.

Prolonged survival when temozolomide is added to accelerated radiotherapy for glioblastoma multiforme

The goal of this study was to evaluate accelerated radiotherapy with and without temozolomide (TMZ) for glioblastoma multiforme (GBM). This retrospective analysis evaluated 86 patients with histologically proven GBM who were treated with accelerated radiotherapy of 1.8 Gy twice daily to a total dose of 54 Gy within 3 weeks. Median age was 62 years and median Karnofsky index was 90. A total of 41 patients received radiotherapy only from 2002-2005 and 45 patients were treated with TMZ concomitantly and after radiotherapy from 2005-2007. Median overall survival (OS) was 12.5 months and 2-year OS was 15.4%. Patient characteristics were well balanced between the two groups except for better performance status (p = 0.05) and higher frequency of retreatment for the first recurrence (p = 0.02) in the TMZ group. Age at diagnosis (HR 2.83) and treatment with TMZ (HR 0.60) were correlated with OS in the multivariate analysis: treatment with and without TMZ resulted in median OS of 16 months and 11.3 months, respectively. Hematological toxicity grade > II was observed in 2/45 patients and 5/37 patients during simultaneous radiochemotherapy and adjuvant TMZ. TMZ added to accelerated radiotherapy for GBM resulted in prolonged overall survival with low rates of severe hematological toxicity.

Does overexpression of VEGFR and TIMP2 predict survival in primary cervical cancer (CC) patients? Results of a companion protocol of the randomized, phase III adjuvant trial of simultaneous cisplatin radiochemotherapy versus sequential carboplatin and paclitaxel followed by radiotherapy.

e15507 Background: Aim of the study was to analyse the expression-profile of IGF1, IGFBP3, sICAM1, sVCAM1, MMP2, MMP9, TIMP2, VEGF, VEGFD, VEGFC and VEGFR in patients with FIGO-stage high-risk Ib-I...

Voice analysis after cancer treatment with organ preservation

BackgroundThis cross-sectional study objects to measure, subjectively and objectively, the voice and life quality of patients with oral cavity, pharyngeal and laryngeal cancer, after organ-preservation treatment.Methods25 cases diagnosed and treated at a high complexity oncology center in southeastern Brazil. All had oral cavity, pharyngeal or laryngeal cancer, with a therapeutic proposal of radiotherapy alone or simultaneous radiochemotherapy. Acoustic voice analysis and the Voice Handicap Index protocol were used to measure voice quality. The data were analyzed through the χ2, Student's t and Kruskal Wallis tests. Significance level was 5%.ResultsAfter treatment, 40% complained of hoarseness, 56% complained of throat clearing, and no patient reported aphonia. On the voice quality auditory scale, 36% had moderate dysphonia. Acoustic voice analysis ranged from 184 to 221 Hz in females, and from 92 to 241 Hz in males. As for quality of life, most patients had mild physical, functional and emotional handicaps.ConclusionsChemio-radiation organ preservation protocols in the patients studied may leave the organ but with reduced function which brings communication sequelae. In such cases, voice assessment and quality of life protocols, as well as speech therapy rehabilitation, are important tools to preserve function, measure and treat alterations, and reintegrate patients into the community.

Randomized phase III adjuvant study in high-risk cervical cancer: Simultaneous radiochemotherapy with cisplatin (S-RC) versus systemic paclitaxel and carboplatin followed by percutaneous radiation (PC-R): A NOGGO-AGO-Intergroup Study.

5005 Background: Adjuvant platinum based radiochemotherapy in high-risk cervical cancer is an established treatment strategy to improve overall survival. Based on several trials for primary and rec...

Neoadjuvant radiochemotherapy in advanced rectal tumor

Oncological neoadjuvant therapy contributes to tumor deterioration and/or tumor mass reduction (debulking) prior to surgery. In recent years preoperative neoadjuvant simultaneous radiochemotherapy has become an integral part of the multimodality treatment of advanced colorectal cancer. It is associated with lower acute and long-term toxicity, as well as reduced local recurrence compared with the formerly used postoperative treatment. Radiotherapy is conventionally fractionated with a single 1.8-Gy dose up to a total dose of 45-50.4 Gy. 5-Fluorouracil (5-FU) is simultaneously administered as base drug therapy. By using other cytostatics, such as oxaliplatin, CPT-11 or capecitabine, it was possible to intensify treatment. The objective of this overview is to present the results of corresponding clinical trials which lead to this change in treatment strategy and to give some recommendations for practice.

Using Q-RT-PCR to measure cyclin D1, TS, TP, DPD, and Her-2/neu as predictors for response, survival, and recurrence in patients with esophageal squamous cell carcinoma following radiochemotherapy

The purpose of this study was to evaluate the use of thymidilate synthetase (TS), thymidilate phosphorylase (TP), dihydropyrimidin dehydrogenase (DPD), Her-2/neu, and cyclin D1 as predictors of therapy response, survival, and recurrence in patients with esophageal squamous cell carcinoma (ESCC) following radiochemotherapy. Twenty-six patients with histologically proven intrathoracic, locally advanced ESCC (cT3, cN0/+, cM0) underwent preoperative, combined simultaneous radiochemotherapy followed by R0-transthoracic esophagectomy. Because R0 resection is the strongest known independent prognostic factor in this tumor entity, only R0-resected patients were included in this study. Pre-therapeutically taken, formalin-fixed, and paraffin-embedded tumor biopsies were used for laser-assisted microdissection of tumor cells and RNA extraction and subjected to real-time (TaqMan) quantitative reverse transcriptase-polymerase chain reaction (Q-RT-PCR). No significant correlation between clinical or histopathological parameters and the relative gene expression of TS, TP, DPD, or Her-2/neu was observed. However, patients with relative cyclin D1 levels below the median gene expression did not reach median survival compared to the 19.9 months seen in patients with relative cyclin D1 gene expression above the median (P = 0.02). Patients with low cyclin D1 levels experienced significantly less frequent recurrence of the tumor (20% versus 63%; P = 0.006), and there was a significant difference in the recurrence-free interval (P = 0.003). Despite the small number of investigated patients, our data seem to show that high levels of cyclin D1 measured by real-time Q-RT-PCR before neoadjuvant radiochemotherapy correlate significantly with patient survival, tumor recurrence, and recurrence-free-interval. Cyclin D1 might be useful in identifying patients at high risk of poor prognosis and suffering from recurrence after neoadjuvant radiochemotherapy treatment and R0 resection. Further investigations with a larger cohort are warranted.

Complete Remission after Neoadjuvant Chemoradiation in a Stage IV Vulvar Cancer Patient

Surgery is the standard in the management of vulvar cancer. Several studies assessed the feasibility of radiochemotherapy as definitive therapy and/or neoadjuvant procedure in order to limit the extent of surgery. Combined radiochemotherapy is associated with considerable toxicity. The authors report on a modified neoadjuvant radiochemotherapy schedule which is isoeffective to the GOG (Gynecologic Oncology Group) protocol, but associated with less therapy-related toxicity. A 36-year-old woman with stage IV vulvar cancer and long-distance rectal infiltration is reported. Laparoscopic pretherapeutic staging confirmed pelvic and paraaortic lymph node metastases. The patient received a neoadjuvant radiochemotherapy. After complete remission, a simple vulvectomy carried out 3 months later showed no evidence of tumor. Up to now, there is no evidence of tumor progression or recurrence. Preoperative conventionally fractionated simultaneous radiochemotherapy seems to be a feasible and safe treatment option for patients with locally advanced vulvar cancer in order to avoid exenterative surgery.

Long-term results of a prospective multicenter phase II study to preserve the larynx function using concomitant boost radiochemotherapy with Carboplatin

Purpose This prospective phase II study was undertaken to assess the feasibility of a larynx preservation protocol with simultaneous radiochemotherapy. Patients and methods Between 3/1998 and 10/2000, 42 patients with moderately advanced cancer of the larynx ( n = 25) and hypopharynx ( n = 17) eligible for total laryngectomy (LE) were treated in a prospective larynx preservation study. The study protocol scheduled 66 Gy in 5 weeks using a concomitant boost technique and 70 mg/m 2 Carboplatin on days 1–5 in weeks 1 and 5. Results The median follow-up time of the censored study patients was 41 months (9–95 months). The 5-year overall survival was 0.66 (95% CI 0.48–0.84), the 5-year laryngectomy-free survival 0.60 (95% CI 0.42–0.78), and the laryngeal preservation rate at 5 years 0.67 (95% CI 0.49–0.85). Cox multivariate regression analysis showed the total tumor volume to be the only statistically significant factor on locoregional failure-free survival. Six of 23 tumor-free long-term survivors received a tracheotomy because of late laryngeal toxicity associated with dysphagia 30–79 months after radiochemotherapy. Conclusions Due to the late laryngeal toxicity observed the value of this regimen for larynx preservation is limited.

Radiochemotherapy with Cisplatin and Oral Tegafur in Advanced Head and Neck Cancer: Long-Term Results of a Phase II Study

To evaluate the tolerance and efficacy of an original concurrent radiochemotherapy regimen in locally advanced head and neck cancer. Sixty-four patients with stage III or IV squamous cell carcinoma arising from a head and neck mucosal site were eligible. Simultaneous radiochemotherapy consisted of two courses of continuous infusional cisplatin (20 mg/m2/d, days 1-4 and 29-32) and oral tegafur (1200 mg/d, days 1-14 and 29-43), together with conventional radiation therapy up to a total dose of 70-75 Gy over nine weeks. All the patients were evaluated for toxicity and response. Acute mucositis was the most prevalent complication. Grade 3 toxicities were mucositis (44%), skin toxicity (10%), leukopenia (8%), and thrombocytopenia (1%). No toxic death was observed. Complete response to treatment was observed in 72% of patients. With a median follow-up of 48.5 months (range, 27-84), 5-year actuarial rate of local-regional control, disease-free survival, overall survival and disease-specific survival were 60% (95% confidence interval [CI], 40-70%), 55% (95% CI, 45-65%), 51% (95% CI, 43-59%) and 61% (95% CI, 53-69%), respectively. Response, local-regional control and survival rates are equivalent to those reported from other concomitant radiochemotherapy combinations. However, the regimen offers the advantage of its tolerance and toxicity profile.