Cetuximab versus cisplatin concurrent with IMRT in locally advanced head and neck cancer (LAHNC)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e17030-e17030 ◽  
Author(s):  
S. L. Galper ◽  
H. Deshpande ◽  
M. G. Rose ◽  
R. H. Decker
Keyword(s):  
Treatment Time ◽  
Randomized Study ◽  
Locally Advanced ◽  
Late Toxicity ◽  
Distant Metastases ◽  
Overall Treatment Time ◽  
Tumor Registry ◽  
Altered Fractionation ◽  
N Stage

e17030 Background: Concurrent chemoradiation of LAHNC with cetuximab or cisplatin improves survival. The purpose of this study is to compare cetuximab chemoradiation (ExRT) with cisplatin chemoradiation (ChRT) in patients treated with IMRT. Methods: Between January 2005 and August 2008, 24 patients with LAHNC were treated with definitive chemoradiation utilizing IMRT. ExRT was reserved for those whose age or comorbidities precluded ChRT. 15 patients were treated with ChRT and 9 patients were treated with ExRT. Patient charts and Tumor Registry data were reviewed for acute and late toxicity and for local/regional failure (LRF), distant metastases and death. Results: The ExRT cohort was significantly older (median age 71 vs 58, p=0.005) and had more larynx/hypopharynx primaries (44% vs 27%). The cohorts were otherwise balanced with respect to T- and N-stage. Median follow-up for the ExRT and ChRT cohorts was 11 and 12 months, respectively. Overall treatment time in compliant patients was lower in ExRT patients (46 vs 50 days, p=0.05), reflecting increased use of accelerated radiation fractionation (66% vs 40%). See Table for toxicity outcomes. There was a trend toward increased ≥G3 acute mucositis in the ExRT group (p=0.07). However, there was less weight loss (p=0.05). There were similar acute epidermitis and hospitalizations for malnutrition/hydration rates and a nonsignificant decrease in prolonged mucosal toxicity. 1 patient developed skin necrosis and another osteoradionecrosis in the ChRT group. 1-year freedom from LRF was 89% in the ChRT group vs 56% in the ExRT group (p=0.07). Overall survival (OS) at 1 year was 100% (ChRT) vs 88% (ExRT). Conclusions: ExRT showed a trend toward worse acute mucosal toxicity but not late toxicity despite increased rates of altered fractionation with a higher daily dose. ExRT was associated with worse LRC and OS. A randomized study would best compare outcomes and toxicity profiles. Until such analysis, cetuximab should be reserved for patients unable to tolerate ChRT. [Table: see text] No significant financial relationships to disclose.

scholarly journals MR-guided SBRT boost for patients with locally advanced or recurrent gynecological cancers ineligible for brachytherapy: feasibility and early clinical experience

2022 ◽  
Vol 17 (1) ◽  
Author(s):  
Indrawati Hadi ◽  
Chukwuka Eze ◽  
Stephan Schönecker ◽  
Rieke von Bestenbostel ◽  
Paul Rogowski ◽  
...  
Keyword(s):  
Treatment Time ◽  
Gynecological Cancer ◽  
Locally Advanced ◽  
Standard Of Care ◽  
Overall Treatment Time ◽  
Adaptive Workflow ◽  
Early Results ◽  
Long Term Follow Up ◽  
Median Cumulative Dose

Abstract Background and purpose Chemoradiotherapy (CRT) followed by a brachytherapy (BT) boost is the standard of care for patients with locally advanced or recurrent gynecological cancer (LARGC). However, not every patient is suitable for BT. Therefore, we investigated the feasibility of an MR-guided SBRT boost (MRg-SBRT boost) following CRT of the pelvis. Material and methods Ten patients with LARGC were analyzed retrospectively. The patients were not suitable for BT due to extensive infiltration of the pelvic wall (10%), other adjacent organs (30%), or both (50%), or ineligibility for anesthesia (10%). Online-adaptive treatment planning was performed to control for interfractional anatomical changes. Treatment parameters and toxicity were evaluated to assess the feasibility of MRg-SBRT boost. Results MRg-SBRT boost was delivered to a median total dose of 21.0 Gy in 4 fractions. The median optimized PTV (PTVopt) size was 43.5ccm. The median cumulative dose of 73.6Gy10 was delivered to PTVopt. The cumulative median D2ccm of the rectum was 63.7 Gy; bladder 72.2 Gy; sigmoid 65.8 Gy; bowel 59.9 Gy (EQD23). The median overall treatment time/fraction was 77 min, including the adaptive workflow in 100% of fractions. The median duration of the entire treatment was 50 days. After a median follow-up of 9 months, we observed no CTCAE ≥ °II toxicities. Conclusion These early results report the feasibility of an MRg-SBRT boost approach in patients with LARGC, who were not candidates for BT. When classical BT-OAR constraints are followed, the therapy was well tolerated. Long-term follow-up is needed to validate the results.

A Randomized Comparison of Cisplatin and Oral Vinorelbine as Radiosensitizers in Aged or Comorbid Locally Advanced Cervical Cancer Patients

2013 ◽  
Vol 23 (5) ◽  
pp. 884-889 ◽  
Author(s):  
Jaime Alberto Coronel ◽  
Lucely del Carmen Cetina ◽  
David Cantú ◽  
Oscar Cerezo ◽  
Cintia Sánchez Hernández ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Treatment Time ◽  
External Beam Radiotherapy ◽  
Randomized Study ◽  
Locally Advanced ◽  
Advanced Cervical Cancer ◽  
Overall Treatment Time ◽  
Aged Patients ◽  
Oral Vinorelbine ◽  
Locally Advanced Cervical Cancer

ObjectiveChemoradiation with cisplatin is considered the standard of care for patients with locally advanced cervical cancer; however, cisplatin could be difficult to use in aged patients or patients with comorbidities such as diabetes mellitus and blood hypertension; hence, it is important to investigate nonplatinum drugs for radiosensitization. In addition, oral cytotoxics may overcome the drawbacks of intravenous infusions and could be of easier administration.MethodsIn this small randomized trial, we tested cisplatin against oral vinorelbine as radiosensitizers in these patients. A total of 39 patients 65 years or older or diabetic and hypertensive patients of any age were randomized to cisplatin or oral vinorelbine at 40 mg/m2 or 60 mg/m2, respectively. Both drugs were administered weekly for 6 courses during pelvic external-beam radiotherapy and brachytherapy radiation. Efficacy and safety were assessed.ResultsNineteen patients received oral vinorelbine, and 20 patients received cisplatin. The median cumulative dose to point A was 80.8 Gy for both groups, and the overall treatment time was 48 (42–54) and 50 (43–55) days for vinorelbine and cisplatin groups, respectively. Patients in both arms received a median of 5 applications of chemotherapy. Treatment was well tolerated in both arms. The most frequent toxicity in both arms was lymphopenia grades 2 and 3. At a median follow-up time of 16 months (4–19), there were no differences in either progression-free survival or overall survival between groups.ConclusionsOur results suggest that these patient populations can safely be treated with either cisplatin or navelbine as radiosensitizers; however, a larger randomized study is needed to demonstrate the noninferiority of oral vinorelbine as an easier and practical alternative for radiosensitization in cervical cancer.

Altered Fractionation Schedules in Radiotherapy of Head and Neck Cancer. A Review

1992 ◽  
Vol 78 (5) ◽  
pp. 311-325 ◽  
Author(s):  
Carlo Fallai ◽  
Patrizia Olmi
Keyword(s):  
Total Dose ◽  
Head And Neck ◽  
Local Control ◽  
Randomized Trials ◽  
Treatment Time ◽  
Dose Intensity ◽  
Field Size ◽  
Overall Treatment Time ◽  
Altered Fractionation ◽  
Improvement In Survival

The authors review the main contributions of international literature to show the current status in clinical trials on unconventional fractionations of the dose in radiotherapy of head and neck cancers. Several clinical (but only a few randomized) trials have been conducted over the last 15 years using hyperfractionated (HF), accelerated (AF) or mixed (HF-AF) schedules. HF schedules have obtained promising results in terms of local control in comparison with conventional fractionation (CF) of the dose. Improvement in survival was also obtained by the random trials of Pinto and Sanchiz, whereas in EORTC trial no. 22791, the improvement in survival rate was only marginal. A significant increase in local control and, less frequently, in survival has been claimed in several studies using HF-AF. Such data still need to be confirmed by a random study, since EORTC trial 22811 showed superimposable results in comparison with CF. Selection of the most suitable cases for altered fractionation schemes is also being studied in ongoing trials of the EORTC (22851) and RTOG (90-03). As regards acute reactions during and after altered fractionation, they are more severe than after CF. Only pure HF with a dose intensity approximately comparable to CF seems to produce similar acute reactions. Several factors have been found to influence the severity of acute mucosal reactions: interfraction interval, overall treatment time, total dose, and field size. As regards late damage, genuine HF schemes seem to cause roughly equivalent late damage in comparison to CF, whereas high-dose intensity schedules have a higher rate of complications. Interfraction interval, overall treatment time, total dose, fraction size and field size can influence the risk of late sequelae. Before altered fractionations can be considered standard therapy, more data are needed, which should be provided by multicentric randomized trials, some of which are already in progress.

The influence of overall treatment time to the efficiency of chemo-radiotherapy for locally advanced cervical cancer

2017 ◽  
Vol 17 (1) ◽  
pp. 124-130
Author(s):  
Ekkasit Tharavichitkul ◽  
Panupat Rugpong ◽  
Nisa Chawapun ◽  
Razvan M. Galalae
Keyword(s):  
Cervical Cancer ◽  
Treatment Time ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Intracavitary Brachytherapy ◽  
Treatment Results ◽  
Overall Treatment Time ◽  
Free Survival ◽  
Significant Difference ◽  
The Mean

AbstractPurposeThis study aims to clarify the influence of overall treatment time (OTT) on the efficiency of combined chemo-radiotherapy in cervical cancer.Material and methodsThis retrospective study enrolled 122 cervical cancer patients who had squamous cell carcinoma and had undergone definitive chemo-radiotherapy from 2009 to 2013. All patients received whole pelvic radiotherapy (WPRT) with the dose of 50 Gy in 25 fractions (with central shielding after 44 Gy) plus intracavitary brachytherapy with the dose of 28 Gy in four fractions. During WPRT, all patients received concurrent chemotherapy with weekly platinum-based regimen. The data of patient characteristics, OTT, treatment results and toxicities were collected and evaluated.ResultsThe mean follow-up time was 36 months. The mean age of patients was 52 years old; 68% of patients were stage IIB related to International Federation of Gynaecology and Obstetrics staging. Pelvic control (PC), distant metastasis-free survival (DMFS), disease-free survival (DFS) and overall survival (OS) rates did not differ significantly in the data-derived cut points of 55·8 and 53 days. No statistically significant difference in treatment results between the two groups of OTT<49 and OTT≥62 days was observed.ConclusionsIn our data-derived cut point, OTT did not influence to PC, DMFS, DFS and OS. The influence of OTT on treatment results may be found in longer periods.

Altered Fractionation in Radiotherapy

1998 ◽  
Vol 84 (2) ◽  
pp. 155-159 ◽  
Author(s):  
Riccardo Valdagni
Keyword(s):  
Treatment Time ◽  
Clinical Results ◽  
Therapeutic Benefit ◽  
Phase Iii ◽  
Overall Treatment Time ◽  
Conventional Fractionation ◽  
Normal Tissues ◽  
Normal Tissue Damage ◽  
Altered Fractionation ◽  
Cell Repopulation

Differences between late-responding (slowly proliferating) normal tissues and early-responding (rapidly proliferating) normal tissues and tumor cells and the event of tumor cell repopulation occurring during treatment have essentially led to the development of altered fractionation schemes. Altered fractionation regimens mainly refer to schedules utilising two or more (small dose) fractions per day for part of or for the entire treatment course. It must be underlined that a true standard or conventional fractionation regimen does not exist: no schedule is universally recognised as the standard of reference to be compared with. However, continental European and U.S. conventional regimens are the considered control arm with which the new experimental regimens have to be compared. For this reason they are generally recognised as the standards. The basic rationale for hyperfractionated or accelerated regimens respectively lies in the possibility (a) to deliver higher total doses reducing late-responding normal tissue damage, (b) to deliver total doses in a reduced overall treatment time to defeat tumor clonogen repopulation. Multiple fractions per day should not be delivered with interfraction intervals smaller than 6 hours. Clinical results of phase I-II and limited but convincing phase III randomised trials suggest that a therapeutic benefit can be achieved with new altered regimens.

Induction chemotherapy (ICT) followed by pre-operative chemoradiotherapy in locally advanced rectal cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 13531-13531
Author(s):  
Y. Elkerm ◽  
M. Elrewiny ◽  
S. Al-Batran ◽  
E. Jager ◽  
A. Elsaid
Keyword(s):  
Tumor Regression ◽  
Randomized Study ◽  
Locally Advanced ◽  
Advanced Rectal Cancer ◽  
Locally Advanced Rectal Cancer ◽  
R0 Resection ◽  
Low Toxicity ◽  
Delayed Complications ◽  
Pathological Cr

13531 Background: Preoperative radiotherapy (RT)with or without chemotherapy (CRT) for patients (ptns) with T3,4 rectal carcinoma is increasingly accepted.We presented, 3 yrs ago, our experience with Cisplatin-5FU-Folonic(FA)regimen (FOLFC) in patns with metastatic CR carcinoma.We proved it is comparable to other regimens with lower cost. Methods: Between 10/99 & 8/04, 104 ptns between 18 and 65 year old (PS 0–1) were assessed retrospectively (24 T3 & 80 T4). Ptns received 2 months of ICT Cis(40mg/m2 D1)+FA(200mg/m2 2hrs infusion D1,2)followed by 5FU bolus(400 mg/m2 D1,2)+5FU cont inf(1200 mg/m2 D1–2)this cycle repeated q 2 wks for 8 wks. Starting on wk 9, 5 FU-FA was given as in Mayo-clinic regimen (D1–5, D21–25) with concomitant RT 45Gy in 25 fractions followed by 9 Gy boost to primary tumor. TME was planned at 4–6 wks from completion of ICT. 2 more cycles of FOLFC was given post-operatively. Results: All ptns (104) undergoing CRT completed therapy as planned, with no treatment-related interruptions. No GIII-IV toxicity. The radiological RR (after ICT) was 75% and (4 wks after CRT) was 89% (20CRs, 73PRs). 92% of ptns had subjective R in a median of 24 days from start of ICT in terms of improvement of diarrhea/constipation (90.4%), in obstructive symptoms (40/ 50 ptns)&weight gain in 100% of ptns.Reduced rectal bleeding (100%) & pelvic pain (100%). 17 of 20 ptns who were considered to be inoperable prior to the treatment underwent TME with negative radial margins. Anastomotic leakage occurred in 8 ptns (7.7%). Wound infection occurred in 4 ptns (3.8%). Delayed complications occurred in 3 ptns one required surgery for a stomal stricture. All ptns underwent R0 resection with clear CRM. Pathological CR was found in 32 ptns and in an additional 41 ptns, only microscopic tumor foci were found on surgical specimens. After a median follow-up of 16 months, two ptns had developed LR. Conclusions: ICT followed by synchronous CRT and TME results in marked tumor regression, rapid symptomatic response and achievement of R0 resection. The majority of ptns considered inoperable prior to receiving this treatment underwent successful excision. Given the low toxicity and promising activity, this regimen is being compared to standard synchronous 5FU- pelvic chemoradiation in a randomized study. No significant financial relationships to disclose.

Carbon ion radiotherapy for malignant melanoma of female genital organs

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e16548-e16548
Author(s):  
H. Kiyohara ◽  
S. Kato ◽  
T. Ohno ◽  
Y. Ohkubo ◽  
T. Tamaki ◽  
...  
Keyword(s):  
Malignant Melanoma ◽  
Late Toxicity ◽  
Distant Metastases ◽  
Local Tumor Control ◽  
Carbon Ion Radiotherapy ◽  
Tumor Control ◽  
Carbon Ion ◽  
Locally Recurrent ◽  
Female Genital

e16548 Background: Malignant melanoma of the female genital organs is a very rare tumor and resistant to conventional photon radiotherapy. We report six cases of female genital malignant melanoma those were well controlled locally by carbon ion radiotherapy (CIRT). Methods: Between November 2004 and October 2008, six patients with unresectable female genital malignant melanoma were treated with CIRT. Age of the patients ranged from 55 to 80 years (median; 69 years). Four patients had previously untreated locally invasive tumors and other two had locally recurrent tumors after surgery and adjuvant chemotherapy. The tumor located in the vagina (4 patients), both the cervix and the vagina (1 patient), or both the vagina and the vulva (1 patient). Two patients had inguinal lymph node metastasis and two had distant metastases at CIRT. All patients received a total dose of 57.6 gray equivalent (GyE) in 16 fractions over 4 weeks of CIRT. Three patients received chemotherapy using dacarbazine, ACNU, and vincristine after CIRT. Results: The follow-up durations after CIRT were from 9 to 20 months (median; 13 months). No patient developed severe acute toxicity during CIRT. No late toxicity of greater Grade 2 was experienced, while Grade 1 proctitis was observed in a patient. All tumors completely responded to CIRT. No patient developed in-field recurrence. The four patients without distant metastasis were alive with no evidence of disease for 9–20 months after CIRT. The two patients with distant metastases died from metastatic disease 13 and 18 months after CIRT, respectively. Conclusions: CIRT achieved favorable local tumor control without developing severe acute and late toxicity in the treatment of unresectable malignant melanoma of the female genital organs. No significant financial relationships to disclose.

Phase I/II study on stereotactic hypofractionated once-weekly radiation therapy (SHORT) for localized prostate cancer.

2017 ◽  
Vol 35 (6_suppl) ◽  
pp. 130-130 ◽  
Author(s):  
Indranil Mallick ◽  
Moses Arunsingh ◽  
Sriram Prasath ◽  
B Arun ◽  
Paromita Roy ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trial ◽  
High Risk ◽  
Phase I ◽  
Treatment Time ◽  
Late Toxicity ◽  
Biochemical Control ◽  
Overall Treatment Time ◽  
Risk Patients ◽  
Prescription Dose

130 Background: The low α/β ratio of prostate cancer (PrCa) is well established. However, stereotactic hypofractionated radiotherapy (SRT) has been investigated primarily in highly selected patient populations with low-intermediate risk disease. We performed a clinical trial of SRT delivered in once-weekly fractions on an unselected cohort of patients with non-metastatic PrCa. Methods: In this Phase I/II study 30 patients with non-metastatic PrCa (multiparametric MRI cT1-4N0, M0, Gleason 6-10, PSA < = 60 ng/ml) were treated with SRT to a prescription dose of 35Gy in 5 fractions delivered once a week (overall treatment time 29 days). Elective nodal RT at 25Gy/5Fr was delivered in patients high-risk by NCCN criteria, and androgen deprivation therapy given to intermediate and high-risk patients. SRT was planned using volumetric intensity modulated arc therapy (VMAT) or Helical Tomotherapy (HT) with pre-defined dose-criteria. The primary endpoint was acute toxicity NCI CTC v4, and secondary endpoints were biochemical control and late toxicity. Results: Thirty patients completed treatment per-protocol. Stage T3, Gleason 8-10, and PSA > 10 was seen in 18 (60%), 7 (23%) and 24 (80%) respectively. Overall 20 (66.7%) were high-risk. Median of Mean PTV dose was 36Gy, and normal tissue constraints could be met in all patients (Table). Acute urinary toxicities (Gr 0: 1; Gr 1: 27; Gr 2: 1; Gr 3-4: 0) and acute rectal toxicities (Gr 0: 20; Gr 1: 10; Gr 2: 0; Gr 3-4: 0) were very modest. The mean IPSS scores at baseline, end of treatment and 3 months after treatment were 8.8, 14.7, and 9.9. With a median follow up of 23.7 months, the 2 year biochemical control was 96%. Late grade 2 rectal bleeding developed in 1 patient. Conclusions: Carefully planned stereotactic VMAT/HT based once-weekly SRT to a predominantly high-risk non-metastatic PrCa cohort was very well tolerated and found to be safe for clinical use. Preliminary biochemical control and late toxicity profiles are encouraging. Clinical trial information: CTRI/2016/02/006671. [Table: see text]

Nomograms for Predicting Local Recurrence, Distant Metastases, and Overall Survival for Patients With Locally Advanced Rectal Cancer on the Basis of European Randomized Clinical Trials

2011 ◽  
Vol 29 (23) ◽  
pp. 3163-3172 ◽  
Author(s):  
Vincenzo Valentini ◽  
Ruud G.P.M. van Stiphout ◽  
Guido Lammering ◽  
Maria Antonietta Gambacorta ◽  
Maria Cristina Barba ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Adjuvant Chemotherapy ◽  
Local Recurrence ◽  
External Validation ◽  
Locally Advanced ◽  
Distant Metastases ◽  
Risk Groups ◽  
Advanced Rectal Cancer ◽  
Locally Advanced Rectal Cancer

Purpose The purpose of this study was to develop accurate models and nomograms to predict local recurrence, distant metastases, and survival for patients with locally advanced rectal cancer treated with long-course chemoradiotherapy (CRT) followed by surgery and to allow for a selection of patients who may benefit most from postoperative adjuvant chemotherapy and close follow-up. Patients and Methods All data (N = 2,795) from five major European clinical trials for rectal cancer were pooled and used to perform an extensive survival analysis and to develop multivariate nomograms based on Cox regression. Data from one trial was used as an external validation set. The variables used in the analysis were sex, age, clinical tumor stage stage, tumor location, radiotherapy dose, concurrent and adjuvant chemotherapy, surgery procedure, and pTNM stage. Model performance was evaluated by the concordance index (c-index). Risk group stratification was proposed for the nomograms. Results The nomograms are able to predict events with a c-index for external validation of local recurrence (LR; 0.68), distant metastases (DM; 0.73), and overall survival (OS; 0.70). Pathologic staging is essential for accurate prediction of long-term outcome. Both preoperative CRT and adjuvant chemotherapy have an added value when predicting LR, DM, and OS rates. The stratification in risk groups allows significant distinction between Kaplan-Meier curves for outcome. Conclusion The easy-to-use nomograms can predict LR, DM, and OS over a 5-year period after surgery. They may be used as decision support tools in future trials by using the three defined risk groups to select patients for postoperative chemotherapy and close follow-up ( http://www.predictcancer.org ).

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