comparison of response, toxicity evaluation & one year survival in cases of unresectable locally advanced esophageal cancer, when using CCRT/SCRT as definitive treatment.
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case study- CCRT vs SCRT in unresectable locally advanced esophageal cancer
1. Co- Authors
Prof. (Dr.) Ramesh Arya, Dr. Preety Jain, Dr. Manish Verma, Dr. Om Prakash Gurjar, Dr. Ayush Naik
Govt. Cancer Hospital, MGM Medical College, Indore
Dr. Abhishek Pratap Singh
Resident, Dept. Of Radiation Oncology,
M.G.M. Medical College, Indore
A Randomized study to compare concurrent
chemoradiotherapy versus sequential chemoradiotherapy in
unresectable locally advanced esophageal cancers.
2. Background
Esophageal carcinoma is a malignant disease with a poor prognosis.
It is the sixth leading cause of cancer-related death worldwide.
Traditionally, carcinoma of the esophagus has been treated by
surgery or radiation therapy, but only 30% esophageal cancers are
resectable at the time of diagnosis and, 5-year survival is 70-90% in
these patients.
Overall 5-year survival rates have been only 5-10%, mainly in
advanced stages.
In unresectable cases , using CCRT or SCRT as definitive treatment
modality, toxicity must also be considered in the context of overall
therapeutic gain.
3. Aim of the Study
To compare treatment response and toxicity evaluation between
concurrent chemoradiotherapy (CCRT) and sequential
chemoradiotherapy (SCRT) in unresectable, locally advanced,
esophageal squamous cell carcinoma (ESSC).
4. Methods and Materials;
Inclusion Criteria
Patients of age group >18 years, of either sex.
Patients with Karnofsky Performance status (KPS) >60.
Advanced stage patients of squamous cell carcinoma esophagus, (AJCC,2019-
stage II & III).
Exclusion Criteria
Patients received Prior radiotherapy to thorax and/or chemotherapy.
Patients having Tracheoesophageal fistula & definitive surgery.
There should Not be other comorbidities.
5. Treatment
Total
patients
n=60
Group
A CCRT
(n=30)
50 Gy in 25# @ 2Gy/# over 5 weeks along with concurrent
cisplatin (75 mg/m2) IV on day 1 and 5-FU (750 mg/m2)
continuous IV infusion on days 1-4; starting on the first day
of irradiation and repeated after 21 days.
Group
B
SCRT
(n=30)
Two cycles of chemotherapy, cisplatin (75 mg/m2)
on day 1 and 5-FU (750 mg/m2) continuous IV
infusion on days 1-4, at a gap of 21 days; followed
21 days, by radiotherapy in the dose fractionation
50 Gy in 25#@2Gy/#, over 5 weeks.
Groups
6. Radiotherapy was administered by External beam
radiotherapy with a megavoltage beam utilizing
Theratron 780-C cobalt machine with 80 cm SSD.
In phase I plan, 36 Gy in 18 fractions.
In phase II plan up to the total dose of 50.0 Gy.
During phase I of treatment, AP-PA field portals
were drawn.
For phase II, two anterior oblique wedge portals
in upper1/3rd tumor and one anterior and two
posterior oblique portals in middle and lower
1/3rd tumor were used, respectively.
7. PRIMARY SITE OF TUMOR;
0
10
20
30
40
50
Cervical Lower Middle Upper
18.3 18.3
45
18.3
Percentage(%)
Site of Primary
Distributionof study participants
accordingto the site of primary
Graph 1 Bar Diagram Showing Distribution of Study Participants
According to the Site of primary Tumor.
Observation
8. Distribution of study participants in the different arms according to the
response of the treatment.
0
10
20
30
40
50
60
70
CR PD PR SD
70
10 13.3
6.7
33.3
13.3
30
23.3
Percentage(%)
Response
Distributionof study participants in the
differentarms according to the response
CCRT
SCRT
Graph 2; Bar Diagram showing Distribution of study Participants in
Different Arms According to The Response.
RESPONSE ASSESSMENT;
9. ;
Toxicity Assessment
0
20
40
60
80
100
CCRT SCRT
16.7
8083.3
20
Percentage(%)
Distributionof studyparticipantsin the
differentarmsaccordingtothe mucositisgrade
Mucosititis Grade 0 and 1 Mucosititis Grade 2 and 3
Graph 3; Bar Diagram showing
Distribution of Study Participants
in the Different arms According to the
Mucositis Grade.
0
10
20
30
40
50
60
70
80
CCRT SCRT
63.3
76.7
36.7
23.3
Percentage(%)
Distribution of study participants in the different
arms according to the acute skin reaction grade
Acute skin reaction Grade 0 and 1 Acute skin reaction Grade 2 and 3
Graph 4; Bar Diagram Showing Distribution of
Study Participants in
Different Arms According to the Acute Skin
Reaction Grade.
10. 0
20
40
60
80
CCRT SCRT
30
56.7
70
43.3
Percentage(%)
Distribution of study participants in the different
armsaccording to the acute GI toxicity grade
AcuteGIToxicity Grade 0 and 1 AcuteGIToxicity Grade 2 and 3
Graph 5; Bar Diagram showing Distribution
of Study Participant in the Different Arm
According to The Acute GI Toxicity Grade.
0
10
20
30
40
50
60
70
80
CCRT SCRT
26.7
7073.3
30
Percentage(%)
Distribution of study participants in the different
arms according to the anemia grade
Anemia Grade 0 and 1 Anemia Grade 2 and 3
Graph 6; Bar Diagram Showing Distribution
of Study Participants in The Different Arm
According to the Anemia Grade.
11. 0
20
40
60
80
100
CCRT SCRT
6.7
53.3
93.3
46.7
Percentage(%)
Distribution of study participants in the different
armsaccording tothe Neutropenia grade
NeutropeniaGrade 0and 1 NeutropeniaGrade 2and 3
Graph 7; Bar Diagram Showing Distribution of Study
Participants in the Different Arm According to the
Neutropenia Grade.
0
20
40
60
80
100
CCRT SCRT
84
96.3
16
3.7
Percentage(%)
Distribution of study participants in the different
arms according to the Late lung toxicity grade
LateLung toxicity Grade 0and 1 LateLung toxicity 2and 3
Graph 8; Bar Diagram showing Distribution of Study
Participants in the Different Arms According to the Late Lung
Toxicity Grade.
13. Conclusions
Response evaluation done monthly after treatment completion,
showed significantly better complete response in CCRT group
compared to SCRT group (p=0.035), while 04 (13.3%) & 09 (30.0%)
showed partial response in respective groups.
Assessment for acute toxicities, showed higher number of subjects
25 (83.3%) in the CCRT group had a mucositis of grade 2 and 3,
whereas majority of patients in the SCRT group 24 (80%) has grade
0 and 1 of mucositis, (p<0.001).
In CCRT group a higher number of subjects (70%) had GI toxicity of
Grade 2 and 3, whereas majority of subjects in SCRT arm (56.7%)
had GI toxicity of Grade 0 and 1 (p=0.037).
14. Hematological complications including Anemia & Neutropenia were
significantly more in CCRT group compare to SCRT group(p<0.001).
While no significant difference in terms of late pulmonary & late renal
toxicity was seen amongst both the groups. The percentage one year
survival was nearly same in both the study groups.
On combining chemotherapy with radiotherapy for the
management of locally advanced unresactable esophageal
concurrent chemoradiation can provide more promising tumor
response than sequential chemoradiation. However, there
be a higher chance of both acute and late toxicities with CCRT
than SCRT.
Most patients with locally advanced esophageal cancer are neither the candidates for surgical treatment, nor they prefer to undergo surgery. Such patients are often treated with chemotherapy and radiotherapy.
Primary radiotherapy is usually reserved for patients with extensive locally advanced disease, that is unresectable or, for patients who are not fit to undergo surgery.
- SECONDARY OBJECTIVES;
[A.] % Survival after one year.
[B.] Toxicity profile.
Pregnant & lactating women.
Patients having Laboratory evidence of renal disease
Patient’s Serum creatinine level <1.4 mg/dl.
Total leukocytes count >3500/mm3
Patient having Hemoglobin >10.0 gm/dl.
Patients with Platelets count >1,00,000/mm3 .
Level of Total bilirubin <2.5 mg/dl.
Pretreatment evaluation;
4.5- Method of Delivering Chemotherapy;
Before the administration of chemotherapy, all patients were premedicated with ranitidine 50 mg IV, dexamethasone 8 mg IV and ondansetron 8 mg IV slowly.
Cisplatin (75 mg/m2) was given IV on day 1 mixed in normal saline 500 ml, with proper hydration and mannitol infusion.
5-FU was (1000 mg/m2) administered by continuous IV infusion on days 1-4, and repeated after 21 days.
Managed conservatively for any treatment or disease related complications.
4.6- Method of Delivering Radiotherapy;
Radiotherapy was administered by External beam radiotherapy with a megavoltage beam utilizing Theratron 780-C cobalt machine with 80 cm SSD.
Conventional fractionated radiotherapy was performed throughout the entire treatment process in both arms, and a total dose of 50.0 Gy was delivered at the rate of 2.0 Gy per fraction (single fraction per day and five fractions per week).
Without correction of tissue heterogeneity, Prescription dose was calculated.
The boundaries of gross target volume (GTV) were marked by use of barium swallow, endoscopy and CT scan. The upper and lower boundaries of clinical target volume (CTV) were defined as an margin of 5 cm outside the upper and lower bounds of GTV, respectively, in phase I plan and 2 cm outside the upper and lower boundaries of GTV, respectively, in phase II plan.
The lateral boundaries of CTV were marked by an extension of 2 cm outside the lateral bounds of GTV.
Immobilization done by use of proper sized neck rest. In phase I plan, 36 Gy in 18 fractions and in phase II plan up to the total dose of 50.0 Gy was delivered by conventional fractionation.
During phase I of treatment, AP-PA field portals were drawn. For phase II, two anterior oblique wedge portals in upper 1/3rd tumor and one anterior and two posterior oblique portals in middle and lower 1/3rd tumor were used, respectively. proper calculation, positioning, & target delineation was done under the guidance of consultant radiation oncologist.
Shielding were also used to prevent lungs irradiation & overexposure of normal tissues.
EVALUATION;
Done at 4 weeks, 8 weeks, & 12 weeks for acute toxicities evaluations.
Done monthly & calculated at the end of 12 months, for response assessment, late toxicities evaluation, % one year survival, & recurrence.
Recurrence
Group
FE test
p-value
CCRT
SCRT
No
14 (66.7%)
7 (70%)
0.999
Yes
7 (33.3%)
3 (30%)
Total
21 (100%)
10(100%)
