scholarly journals Clinical Management and Outcome of Grade III Pneumonitis after Chemoradioimmunotherapy for Inoperable Stage III Non-Small Cell Lung Cancer—A Prospective Longitudinal Assessment

Diagnostics ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. 1968
Author(s):  
Diego Kauffmann-Guerrero ◽  
Julian Taugner ◽  
Chukwuka Eze ◽  
Lukas Käsmann ◽  
Minglun Li ◽  
...  
Keyword(s):  
Lung Function ◽  
Target Volume ◽  
Ct Imaging ◽  
Stage Iii ◽  
High Dose ◽  
Longitudinal Assessment ◽  
Diffusion Capacity ◽  
Grade 3 ◽  
Patient Prognosis ◽  
Prospective Longitudinal

Background: Maintenance treatment with immune-checkpoint inhibition (ICI) has been shown to significantly improve patient prognosis after chemoradiotherapy (CRT) for inoperable stage III NSCLC. This survival advantage may be achieved at the expense of an increased probability for symptomatic pneumonitis as CRT as well as ICI treatment is associated with the risk of treatment-related pulmonary toxicity. Methods: We screened a prospective chemoradioimmunotherapy (CRT-IO) cohort consisting of 38 patients and identified patients with therapy-related grade 3 pneumonitis. All patients were treated with intravenous high dose corticosteroids and closely monitored by CT-scans and extended longitudinal lung function tests. We analyzed lung function parameters and CT morphological features to characterize patients’ outcome. Results: Six (16%) patients treated with CRT-IO developed grade 3 pneumonitis one to six months after completion CRT. In the CT imaging, pneumonitis was characterized by diffuse ground glass capacities and in part pulmonary consolidations within and outside the planning target volume. Onset of pneumonitis was accompanied by a reduction in diffusion capacity in all cases. The mean decline of diffusion capacity was 25.8% [6–53%]. Under treatment with corticosteroids, all patients recovered regarding symptoms and changes in CT morphology. In five out of six patients, diffusion capacity improved to at least 80% of the baseline [80–96%]. One patient showed a significant increase of diffusion capacity after treatment (from 32% to 53%) but reached only 62% of the initial value. Conclusions: Pneumonitis is a severe complication of CRT-IO. High-resolution CT imaging and extended lung function testing proved to be a suitable approach in detecting and monitoring of CRT-IO associated pneumonitis.

Folinic acid modulated bolus 5-FU or infusional 5-FU for adjuvant treatment of patients of UICC stage III colon cancer: Preliminary analysis of the PETACC-2-study

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 3563-3563 ◽  
Author(s):  
A. Carrato ◽  
C. Köhne ◽  
L. Bedenne ◽  
I. Popov ◽  
O. Bouche ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Overall Survival ◽  
Lymphatic Invasion ◽  
Hazard Ratio ◽  
Stage Iii ◽  
High Dose ◽  
Uicc Stage ◽  
Stage Iii Colon Cancer ◽  
Hand Foot Syndrome ◽  
Grade 3

3563 Background: Patients with stage III colon cancer have a high risk for recurrence. Infusional 5-FU may be more active than bolus application. Methods: From 01/1997 to 03/2004 a total of 1601 patients with UICC stage III colon cancer were randomized to receive the Mayo-Clinic regimen or infusional 5-FU either the weekly high dose AIO regimen, the bi-weekly LV5FU2 regimen or the Spanish weekly high dose TTD-regime. The major aim of this study was to demonstrate a difference of 7 % in the 5 year survival rate in favour of the infusional arm for which a total of 424 events were required. Results: After a median follow-up of 31 months 478 events have occurred. 804 patients received the standard arm and 797 the experimental arm (AIO N=331, EORTC N=92, FFCD N=211, TTD N=163). The median age was 64 years; patients were well distributed according to TNM-category (T3 73 vs. 75%, T4 17 vs. 16%, N2 31 vs. 34%), vascular and lymphatic invasion and grading. The bolus regimen induced a higher rate of grade 3 or 4 leukopenia (7.1% versus 2.0%), stomatitis grade 3 or 4 (9.8% versus 3.3%) or diarrhea grade 3 or 4 (16% vs. 15%). Hand-Foot-Syndrome was more frequent in the experimental arm (4.4% versus 0.4%). There was no difference in the recurrence free survival at 5 years (57% versus 56%; hazard ratio 1.00, 95% CI, 0.84 to 1.21; P=0.9) or overall survival at 5 years 71% versus 72%; hazard ratio 0.91, 95% CI, 0.71 to 1.16; P=0.44). Conclusions: Infusional 5-FU does not improve RFS or overall survival of stage III colon cancer compared to the Mayo regimen but is less toxic. Supported by Deutsche Krebshilfe No significant financial relationships to disclose.

Radiotherapy (RT) dose escalation study with concurrent cisplatin and S-1 in patients with inoperable stage III non-small cell lung cancer (NSCLC)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 7542-7542
Author(s):  
H. Harada ◽  
M. Nishio ◽  
H. Murakami ◽  
F. Ohyanagi ◽  
T. Kozuka ◽  
...  
Keyword(s):  
Radiation Dose ◽  
Febrile Neutropenia ◽  
Organs At Risk ◽  
Performance Status ◽  
Target Volume ◽  
Stage Iii ◽  
Eligibility Criteria ◽  
Metastatic Node ◽  
Dose Escalation Study ◽  
Grade 3

7542 Background: Standard treatment for inoperable stage III NSCLC is concurrent chemoradiotherapy using 3-D conformal RT to a total dose of 60 Gy, but the outcome is still dismal with median survival time (MST) of 16 months and 5-year survival of 15%. We conducted a phase II trial using cisplatin, S-1 and concurrent RT of 60 Gy (J Clin Oncol 2008;26:a7556). MST (33months) was encouraging, however, local failure rate with this trial remained still high. The purpose of this study was to establish the recommended dose (RD) of RT with concurrent cisplatin and S-1. Methods: The eligibility criteria were: histologically or cytologically proven NSCLC, 20–75 years old, performance status 0–1, without any prior chemotherapy or RT. Patients were treated with cisplatin (60 mg/m2 on day 1) and S-1 (orally at 40 mg/m2/dose b.i.d., on days 1–14) repeated every 4 weeks for 4 cycles and RT was started on day 1. Radiation dose was escalated from 66 Gy in 33 fractions (Arm 1) to 70 Gy in 35 fractions (Arm 2), then 74 Gy in 37 fractions (Arm 3). The dose was to be escalated if DLTs were observed in 2 or less patients. The target volume of RT included primary tumor and metastatic node only and elective nodal irradiation was not performed. Dose constraints to the organs at risk were: the lung, V20 < 30%; the esophagus, mean dose < 34 Gy and V55 < 30%; the spinal cord, max dose < 50 Gy. Results: Six patients in each arm were enrolled. Two patients in Arm 1 experienced DLTs: one patient developed grade 3 febrile neutropenia, grade 3 mucositis in oral cavity and grade 3 diarrhea and one patient developed grade 3 febrile neutropenia. One patient in Arm 3 has not been completed evaluation yet. Otherwise no DLT was observed. Conclusions: The radiation dose of 74 Gy in 37 fractions with concurrent cisplatin and S-1 seemed to be tolerable and was judged to be the RD. This study is still open to accrue another six patients to confirm the safety of the RD. No significant financial relationships to disclose.

scholarly journals Long-Term Results of NRG Oncology RTOG 0617: Standard- Versus High-Dose Chemoradiotherapy With or Without Cetuximab for Unresectable Stage III Non–Small-Cell Lung Cancer

2020 ◽  
Vol 38 (7) ◽  
pp. 706-714 ◽  
Author(s):  
Jeffrey D. Bradley ◽  
Chen Hu ◽  
Ritsuko R. Komaki ◽  
Gregory A. Masters ◽  
George R. Blumenschein ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Radiation Dose ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Concurrent Chemotherapy ◽  
Small Cell ◽  
Stage Iii ◽  
High Dose ◽  
Small Cell Lung ◽  
Grade 3

PURPOSE RTOG 0617 compared standard-dose (SD; 60 Gy) versus high-dose (HD; 74 Gy) radiation with concurrent chemotherapy and determined the efficacy of cetuximab for stage III non–small-cell lung cancer (NSCLC). METHODS The study used a 2 × 2 factorial design with radiation dose as 1 factor and cetuximab as the other, with a primary end point of overall survival (OS). RESULTS Median follow-up was 5.1 years. There were 3 grade 5 adverse events (AEs) in the SD arm and 9 in the HD arm. Treatment-related grade ≥3 dysphagia and esophagitis occurred in 3.2% and 5.0% of patients in the SD arm v 12.1% and 17.4% in the HD arm, respectively ( P = .0005 and < .0001). There was no difference in pulmonary toxicity, with grade ≥3 AEs in 20.6% and 19.3%. Median OS was 28.7 v 20.3 months ( P = .0072) in the SD and HD arms, respectively, 5-year OS and progression-free survival (PFS) rates were 32.1% and 23% and 18.3% and 13% ( P = .055), respectively. Factors associated with improved OS on multivariable analysis were standard radiation dose, tumor location, institution accrual volume, esophagitis/dysphagia, planning target volume and heart V5. The use of cetuximab conferred no survival benefit at the expense of increased toxicity. The prior signal of benefit in patients with higher H scores was no longer apparent. The progression rate within 1 month of treatment completion in the SD arm was 4.6%. For comparison purposes, the resultant 2-year OS and PFS rates allowing for that dropout rate were 59.6% and 30.7%, respectively, in the SD arms. CONCLUSION A 60-Gy radiation dose with concurrent chemotherapy should remain the standard of care, with the OS rate being among the highest reported in the literature for stage III NSCLC. Cetuximab had no effect on OS. The 2-year OS rates in the control arm are similar to the PACIFIC trial.

Phase I study of concurrent high-dose three-dimensional conformal radiotherapy (3D-CRT) without elective nodal irradiation with chemotherapy using cisplatin and vinorelbine for unresectable stage III non-small cell lung cancer (NSCLC)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 7546-7546
Author(s):  
I. Sekine ◽  
M. Sumi ◽  
Y. Ito ◽  
H. Nokihara ◽  
N. Yamamoto ◽  
...  
Keyword(s):  
Three Dimensional ◽  
Conformal Radiotherapy ◽  
Optimal Dose ◽  
Stage Iii ◽  
High Dose ◽  
Unresectable Stage ◽  
Stage Iii Nsclc ◽  
Grade 3 ◽  
Three Dimensional Conformal Radiotherapy ◽  
3D Crt

7546 Background: The optimal dose of radiotherapy remains unclear in concurrent chemoradiotherapy for unresectable stage III NSCLC. Methods: Eligible patients (unresectable stage III NSCLC, age ≥ 20 years, PS 0–1, V20 ≤ 30%) received cisplatin (80mg/m2 day 1) and vinorelbine (20mg/m2 days 1 and 8) repeated every 4 weeks for 3–4 cycles. The dose of 3D-CRT was 66 Gy in 33 fractions, 72 Gy in 36 fractions, and 78 Gy in 39 fractions at levels 1–3, respectively. The dose-limiting toxicity (DLT), defined as grade ≥3 esophagitis, pneumonitis, myelitis, dermatitis and heart injury, and early stop of protocol treatment, was evaluated in 6–12 patients at each level. Results: Of the 17, 16 and 24 patients assessed for eligibility, 13 (76%), 12 (75%), and 6 (25%) were enrolled into levels 1–3, respectively, of the study. A total of 26 patients were excluded because of V20 > 30% (n=10), overdose to the esophagus (n=8) and brachial plexus (n=2), comorbidity (n=3), or patient refusal (n=3). There were 26 men and 5 women with a median (range) age of 60 (41–75) years. Of these, 23 (74%) had adenocarcinoma and 20 (65%) had stage IIIA disease. The full planned dose of radiotherapy could be administered in all the patients, and more than 80% of the patients received 3–4 cycles of chemotherapy. Grade 3–4 neutropenia and febrile neutropenia were noted in 24 (77%) and 5 (16%) of the 31 patients, respectively. Grade 4 infection, grade 3 esophagitis and grade 3 pulmonary toxicity were noted in one, two and one patients, respectively. DLT was noted in 17% of the patients at each level. Two (6%) complete and 27 (87%) partial responses were obtained. In a preliminary survival analysis, the median progression-free and overall survivals were determined to be 15.0 months and 37.6 months, respectively. Conclusions: At the level of 78Gy, only 25% of the patients assessed for eligibility were actually eligible. Toxicity was relatively mild up to 78 Gy in this highly selective patient group. Thus, we determined that the recommended dose of 3D-CRT administered concurrently with cisplatin and vinorelbine chemotherapy was 72Gy. [Table: see text]

Multicenter phase II study of concurrent high-dose (72Gy) three-dimensional conformal radiotherapy (3D-CRT) without elective nodal irradiation with chemotherapy using cisplatin and vinorelbine for unresectable stage III non-small cell lung cancer (NSCLC).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 7070-7070 ◽  
Author(s):  
Hidehito Horinouchi ◽  
Ikuo Sekine ◽  
Minako Sumi ◽  
Miyako Satouchi ◽  
Hiroshi Isobe ◽  
...  
Keyword(s):  
Three Dimensional ◽  
Conformal Radiotherapy ◽  
Optimal Dose ◽  
Distant Recurrence ◽  
Stage Iii ◽  
High Dose ◽  
Unresectable Stage ◽  
Stage Iii Nsclc ◽  
Grade 3 ◽  
3D Crt

7070 Background: The optimal dose of radiotherapy remains unclear in concurrent chemoradiotherapy for unresectable stage III NSCLC. We previously concluded that the recommended dose for further trial was 72Gy in a phase I study (Sekine et al., Int J Radiat Oncol Biol Phys. 953-959, 2012). Methods: Eligible patients (unresectable stage III NSCLC, age between 20 and 74, PS 0-1, V20 ≤ 30%) received cisplatin (80 mg/m2 day 1) and vinorelbine (20 mg/m2 days 1 and 8) repeated every 4 weeks for 3-4 cycles. The 3D-CRT started at the first day of chemotherapy at a total dose of 72 Gy in 36 fractions. The primary endpoint was a 2-year survival rate and the planned sample size was 60 to reject the rate of 45% under the expectation of 65% with a power of 90% and an alpha error of 5%. Results: Thirty-one patients from 4 institutions were enrolled between May 2009 and March 2010. This trial was terminated early due to slow accrual and grade 5 pulmonary toxicities in 2 patients. There were 25 men and 6 women with a median (range) age of 59 (32-72) years. Of these, 23 had adenocarcinoma and 21 had stage IIIA disease. The median (range) V20 value was 20 (9-30). The full planned dose of radiotherapy could be administered in 30 (97%) patients, and 26 (84%) of the patients received 3-4 cycles of chemotherapy. During the chemoradiotherapy, grade 3-4 febrile neutropenia, infection and esophagitis were noted in 5, 4 and 1 of the 31 patients, respectively. After completion of the planned chemoradiotherapy, 5 patients had grade 3 or higher radiation pneumonitis, and 2 (6%) of these patients died at 6.6 and 7.3 months after the treatment started. The overall response rate was 97% (95% confidence interval: 83.3-99.9). Twenty-four patients are alive and thirteen patients experienced recurrence (2 had loco-regional recurrences, 7 had distant recurrence and 4 had mixed recurrence pattern) at a median follow up of 16.4 months. Conclusions: Concurrent high-dose (72Gy) 3D-CRT with chemotherapy using cisplatin and vinorelbine may have a too excessive incidence of pulmonary toxicities to warrant any further evaluation.

Non-pneumonitis immune-mediated adverse events (imAEs) with durvalumab in patients with unresectable stage III NSCLC (PACIFIC).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 9048-9048
Author(s):  
Jarushka Naidoo ◽  
Johan F. Vansteenkiste ◽  
Corinne Faivre-Finn ◽  
Mustafa Özgüroğlu ◽  
Shuji Murakami ◽  
...  
Keyword(s):  
Stage Iii ◽  
Smoking History ◽  
High Dose ◽  
Thyroid Disorders ◽  
Double Blind ◽  
Unresectable Stage ◽  
Baseline Factors ◽  
Stage Iii Nsclc ◽  
Grade 3 ◽  
Time To Onset

9048 Background: The phase 3 PACIFIC trial established durvalumab (durva) after chemoradiotherapy (CRT) as SoC for pts with unresectable stage III NSCLC. We report exploratory analyses to characterize non-pneumonitis (np) imAEs that occurred with durva in PACIFIC. Methods: PACIFIC was a double blind trial of pts without disease progression after platinum-based concurrent CRT (≥2 cycles). Pts were randomized 2:1 to receive durva 10 mg/kg or placebo (pbo) IV q2w for ≤12 months, stratified by age, sex and smoking history. We characterized the time to onset, duration, and management/outcomes of np imAEs and their association with (1) baseline pt/disease factors and (2) AEs (excluding all-cause pneumonitis). Results: Of 709 treated pts, 19% and 11% experienced imAEs and np imAEs of any grade, respectively; proportionally more had np imAEs with durva (71/475; 15%) vs pbo (5/234; 2%). Thyroid disorders (54/475; 11%), rash/dermatitis (9/475; 2%), and diarrhea/colitis (5/475; 1%) were the most common np imAEs with durva; rash/dermatitis had the shortest time to onset (Table). Among durva treated pts with np imAEs, 11% had grade 3/4 np imAEs, 41% had np imAEs that resolved, and none had fatal np imAEs; interventions included endocrine replacement therapy (73%), systemic corticosteroids (34%), high dose corticosteroids (16%), and discontinuation (10%). There were no apparent differences in baseline factors between pts with or without np imAEs. Durva had a broadly manageable safety profile irrespective of the occurrence of np imAEs. However, a higher proportion of durva treated pts with vs without np imAEs experienced all-cause, grade 3/4 events (41% vs 29%); none were fatal (excl. pneumonitis). Conclusions: Np imAEs occurred infrequently in PACIFIC, but were more common with durva vs pbo; thyroid disorders and rash/dermatitis were the most common np imAEs. Of durva treated pts with np imAEs, 11% experienced np imAEs of grade 3/4. Overall, np imAEs were broadly manageable and did not lead to high rates of discontinuation, and no association with baseline factors was seen, suggesting this should not deter use of durva in eligible pts. Clinical trial information: NCT02125461. [Table: see text]

High dose rate brachytherapy as monotherapy for localized prostate cancer: Our initial experience.

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. e626-e626
Author(s):  
Amarnath Challapalli ◽  
Susan Masson ◽  
Pauline Humphrey ◽  
Frances Bamisaye ◽  
Petra Jacobs ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Dose Rate ◽  
Transrectal Ultrasound ◽  
Target Volume ◽  
High Dose Rate ◽  
Localized Prostate Cancer ◽  
High Dose ◽  
Initial Experience ◽  
Grade 3

e626 Background: High dose rate (HDR) brachytherapy is an attractive treatment option for localized prostate cancer (CaP) as it allows for safe dose escalation and exploits the radiobiological advantage of using a high dose/fraction. We evaluate our early experience in using HDR monotherapy for localized CaP. Methods: Forty patients with low- to intermediate-risk CaP were treated from October 2013-July 2015. Patients had catheters placed transperineally under spinal anaesthesia, using transrectal ultrasound guidance. The clinical target volume [CTV: prostate ± seminal vesicles base] was outlined on a planning CT scan with the catheters and template in-situ. The CTV was grown by 3mm isotropically to obtain the planning target volume (PTV). The catheters were reconstructed and plan optimised according to pre-set dose constraints [DC]. Dose delivered was 19Gy/one fraction. Toxicity was assessed using RTOG criteria. Results: A range of volumes were implanted (20–120 cc, median: 37.5), using a median of 17 needles (range 13–20). Satisfactory implants were achieved in patients with volumes>60cc by excluding pubic arch interference on the pre-implant MRI pelvis. All patients were discharged home within 24 hours, with two patients (5%) requiring re-catheterisation. Good dose coverage to the PTV was achieved: median D90 of 20.4Gy (DC>19Gy), V100 of 95.1% (DC≥95%). Urethral and rectal sparing was satisfactory: urethral D10 of 21.23Gy (DC<22Gy), rectal D2cc of 14Gy (DC<15Gy). The median follow-up was 8 (1-22.6) months. Twenty-five patients, with at least 6 months follow-up showed a median PSA reduction of 80%. Thus far, one had biopsy proven recurrence. Only two patients had grade 3 urinary toxicity and one had grade 3 bowel toxicity at 2 weeks, which returned to baseline at 12 weeks. The IPSS score increased at 2-4 weeks after treatment, but returned to baseline after 3 months. Conclusions: Our initial experience with HDR monotherapy for localized CaP confirms this to be safe, with minimal acute complications. It is possible to implant volumes higher than 60cc, if adequate measures are taken. The early efficacy data for 19Gy is also promising.

Phase II Study of Twice-Daily High-Dose Thoracic Radiotherapy Alternating With Cisplatin and Vindesine for Unresectable Stage III Non–Small-Cell Lung Cancer: Japan Clinical Oncology Group Study 9306

2002 ◽  
Vol 20 (3) ◽  
pp. 797-803
Author(s):  
Ikuo Sekine ◽  
Yutaka Nishiwaki ◽  
Takashi Ogino ◽  
Akira Yokoyama ◽  
Mari Saito ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Total Dose ◽  
Small Cell ◽  
Stage Iii ◽  
High Dose ◽  
Thoracic Radiotherapy ◽  
Small Cell Lung ◽  
Unresectable Stage ◽  
Grade 3

PURPOSE: To evaluate the efficacy and toxicity of high-dose thoracic radiotherapy (TRT) alternating with chemotherapy (CH) for unresectable stage III non–small-cell lung cancer (NSCLC). PATIENTS AND METHODS: Forty-one patients received TRT with 1.5 Gy twice daily, 5 days a week, on weeks 1, 2, 5, 6, and 9, up to a total dose of 66 to 72 Gy, alternating with cisplatin 80 mg/m2 on day 1 and vindesine 3 mg/m2 on days 1 and 8, repeated every 4 weeks, for two or three courses beginning on week 3. RESULTS: The median (range) total dose of TRT and number of CH courses were 72 Gy (16.5 to 72 Gy) and three (zero to three), respectively. Delay in TRT ≥ 5 days was observed in 24 (75%) of 32 patients who completed the projected treatment, due to leukopenia in 12, esophagitis in seven, infection in two, and other causes in three patients. Partial responses were obtained in 36 patients (88%). The median survival time and 3- and 5-year survival rates were 18.4 months, 24%, and 10%, respectively. Grade 3 or 4 leukopenia and esophagitis developed in 32 and seven patients, respectively. Grade 3 or 4 late esophageal toxicity developed in two patients. CONCLUSION: Alternating high-dose TRT and CH for stage III NSCLC produced a high response rate with median and long-term survival comparable to prior trials utilizing standard approaches in this population. Acute and late esophageal toxicity was observed and interruption of TRT was required in most of the patients.

73.6 Gy and Beyond: Hyperfractionated, Accelerated Radiotherapy for Non–Small-Cell Lung Cancer

2001 ◽  
Vol 19 (3) ◽  
pp. 705-711 ◽  
Author(s):  
Patrick D. Maguire ◽  
Lawrence B. Marks ◽  
Gregory S. Sibley ◽  
James E. Herndon II ◽  
Robert W. Clough ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Target Volume ◽  
Small Cell ◽  
High Dose ◽  
Small Cell Lung ◽  
Local Progression ◽  
Grade 5 ◽  
Grade 3

PURPOSE: To assess results with twice-daily high-dose radiotherapy (RT) for non–small-cell lung cancer (NSCLC). PATIENTS AND METHODS: Between 1991 and 1998, 94 patients with unresectable NSCLC were prescribed ≥ 73.6 Gy via accelerated fractionation. Fifty were on a phase II protocol (P group); 44 were similarly treated off-protocol (NP group). The clinical target volume received 45 Gy at 1.25 Gy bid (6-hour interval). The gross target volume received 1.6 Gy bid to 73.6 to 80 Gy over 4.5 to 5 weeks using a concurrent boost technique. Overall survival (OS) and local progression-free survival (LPFS) were calculated by the Kaplan-Meier method. Median follow-up durations for surviving P and NP patients were 67 and 16 months, respectively. RESULTS: Total doses received were ≥ 72 Gy in 97% of patients. The median OS by stage was 34, 13, and 12 months for stages I/II, IIIa, and IIIb, respectively. LPFS was significantly longer for patients with T1 lesions (median, 43 months) versus T2-4 (median, 7 to 10 months; P = .01). Results were similar in the P and NP groups. Acute grade ≥ 3 toxicity included esophagus (14 patients; 15%), lung (three patients; 3% [one grade 5]), and skin (four patients; 4%). Grade ≥ 3 late toxicity in 86 assessable patients included esophagus (three patients; 3%), lung (15 patients; 17% [three grade 5]), skin (five patients; 6%), heart (two patients; 2%), and nerve (one patient; 1%). CONCLUSION: This regimen yielded favorable survival results, particularly for T1 lesions. Acute grade ≥ 3 toxicity seems greater than for conventional RT, though most patients recovered. Late grade ≥ 3 pulmonary toxicity occurred in 17%. Because of continued locoregional recurrences, we are currently using doses ≥ 86 Gy.

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