1. Phase III CONVERT: Twice-Daily vs Once-Daily Concurrent CRT in Limited-Stage SCLC
CCO Independent Conference Coverage* of the 2016 ASCO Annual Meeting, June 3-7, 2016
*CCO is an independent medical education company that provides state-of-the-art medical information to healthcare professionals through conference coverage and other educational programs.
CRT, chemoradiotherapy; SCLC, small-cell lung cancer.
This activity is supported by educational grants from Amgen, Ariad, Bayer Healthcare Pharmaceuticals, Celgene Corporation, Genentech, Incyte, Merck, and Taiho Pharmaceuticals.

2. Once- vs Twice-Daily Concurrent CRT in LS-SCLC (CONVERT): Background
SCLC: 10% to 15% of all lung cancers; ~ 30% present with limited stage or stage I-III disease[1]
Concurrent CRT standard of care for pts with SCLC and good PS
Median OS advantage with twice-daily concurrent CRT vs once-daily CRT (23 vs 19 mos; P = .004)[2]
Grade 3/4 esophagitis: 32% with twice daily vs 16% with once daily
Due to toxicity and logistics, twice-daily RT not widely adopted
In the US, only 21% of patients given twice-daily RT in [3]
Consensus lacking on standard RT regimen for LS-SCLC
Phase III randomized, multinational study compared concurrent twice- daily CRT with once-daily CRT in pts with LS-SCLC and good PS[4]
CRT, chemoradiotherapy; LS, limited-scope; PS, performance status; RT, radiotherapy; SCLC, small-cell lung cancer.
1. Shepherd FA, et al. J Thorac Oncol. 2007;2: Turrisi AT, et al. N Engl J Med ;340: Komaki R, et al. Int J Radiat Oncol Biol Phys. 2012;83:e Faivre-Finn C, et al. ASCO Abstract 8504.
Slide credit: clinicaloptions.com

3. Twice-daily thoracic RT Once-daily thoracic RT
Once- vs Twice-Daily Concurrent CRT in LS-SCLC (CONVERT): Phase III Design
Stratified by center, chemotherapy cycles (4 vs 6), and PS (0-1 vs 2)
Twice-daily thoracic RT
45 Gy/30F/19D*
plus chemotherapy†
(n = 274)
LS-SCLC, ECOG PS 0-1 (or PS 2 if due to disease), FEV1 > 1L or 40% predicted, KCO > 40% predicted
(N = 547)
SD, PR,
or CR
PCI
Once-daily thoracic RT
66 Gy/33F/45D*
plus chemotherapy†
(n = 273)
No PCI
< SD
Primary endpoint: OS
Secondary endpoints: treatment compliance, local PFS, metastatic PFS, toxicity (CTCAE v3.0), exploratory translational objectives including archival tissue, blood samples, germline DNA, and CTCs
3DCRT, 3 dimensional conformal radiotherapy; CTCs, circulating tumor cells; D, days; ECOG PS, Eastern Cooperative Oncology Group performance status; ENI, elective nodal irradiation; F, fractions; FEV1, forced expiratory volume in 1 sec; IMRT, intensity-modulated radiotherapy; KCO, carbon monoxide transfer coefficient; L, liter; LS-SCLC, limited-scope small-cell lung cancer; PCI, prophylactic cranial irradiation; PI, principle investigator; SD, stable disease.
*RT started on Day 22 of chemotherapy Cycle 1 (3DCRT mandatory, IMRT allowed, ENI not allowed)
†4 or 6 cycles of chemotherapy, (prespecified by PI based on their routine practice) Days 1-3, 22-24, 43-45, consisting of cisplatin 25 mg/m2 Days 1-3 or cisplatin 75 mg/m2 Day 1 and etoposide 100 mg/m2 Days 1-3
Slide credit: clinicaloptions.com
Faivre-Finn C, et al. ASCO Abstract 8504.

4. Once- vs Twice-Daily Concurrent CRT in LS-SCLC (CONVERT): Pt Characteristics
Twice-Daily RT + Chemotherapy (n = 274)
Once-Daily RT + Chemotherapy (n = 273)
Median age, yrs (range)
62 (29-84)
63 (34-81)
Male, %
53.7
55.0
ECOG PS, % 1 2
45.6
50.0
3.3
45.1
52.0
2.9
PET-CT staging, %
Yes No
57.3
41.3
57.0
43.0
UICC/AJCC stage, % I II
III
0.4
12.4
79.9
1.1
17.5
75.9
Smoking history
Never
Exsmoker
Current smoker
63.5
34.3
1.5
59.7
38.8
Median gross tumor volume, cc (range)
81.6 ( )
85.6 ( )
AJCC, American Joint Committee on Cancer; CRT, chemoradiotherapy; ECOG PS, Eastern Cooperative Oncology Group performance status; LS-SCLC, limited-scope small-cell lung cancer; RT, radiotherapy; UICC, Union for International Cancer Control.
Slide credit: clinicaloptions.com
Faivre-Finn C, et al. ASCO Abstract 8504.

5. Once- vs Twice-Daily Concurrent CRT in LS-SCLC (CONVERT): Treatment Delivery
Radiotherapy
Twice-Daily RT + Chemo
(n = 274)
Once-Daily RT + Chemo
(n = 273)
No thoracic RT given, %
7.3
9.5
Concurrent CRT, %
Sequential CRT, %
Not known
90.9
1.8 --
87.9
2.2
0.4
IMRT,† %
15.7
17.4
PCI, %
88.0
86.0
Assessed for toxicity,† n
254
246
†Analysis in pts receiving concurrent or sequential CTRT.
Chemotherapy
Twice-Daily RT + Chemo
(n = 274)
Once-Daily RT + Chemo
(n = 273)
Cycles planned, % 4 6
68.6
31.4
67.0
33.0
Cycles delivered, %
58.8
20.4
57.1
19.4
Optimal treatment time achieved, % 64 48
Assessed for toxicity,* n
266
263
*5 pts died before toxicity assessment.
CRT, chemoradiotherapy; IMRT, intensity modulated radiation therapy; LS-SCLC, limited-scope small-cell lung cancer; PCI, prophylactic cranial irradiation; RT, radiotherapy.
RT Treatment Delivery, %
Twice Daily
(n = 249)
Once Daily
(n = 240)
Full dose delivered 98 83
Optimal number of fractions delivered 86 80
Optimal treatment time achieved 64 48
Slide credit: clinicaloptions.com
Faivre-Finn C, et al. ASCO Abstract 8504.

6. Once- vs Twice-Daily Concurrent CRT in LS-SCLC (CONVERT): OS
Twice-Daily RT (n = 273)
Once-Daily RT (n = 270)
HR (95% CI;
P Value)
Median OS, mos
(95% CI)
30 (24-34)
25 (21-31)
1.17 ( ; P = .15)
1 yr, % (95% CI)
83 (78-87) 76
(71-81)
2 yr, % (95% CI)
56*
(50-61) 51
(45-57)
3 yr, % (95% CI) 43
(37-49) 39
(33-45)
CRT, chemoradiotherapy; LS-SCLC, limited-scope small-cell lung cancer; RT, radiotherapy.
Median follow-up: 45 mos
Slide credit: clinicaloptions.com
Faivre-Finn C, et al. ASCO Abstract 8504.

7. Once- vs Twice-Daily Concurrent CRT in LS-SCLC (CONVERT): PFS
Time to Progression (N = 543)
Twice-Daily Concurrent CRT
Once-Daily Concurrent CRT
P Value
Overall progression, n
Median TTP, mos (95% CI)
182
15 (13-19)
190
14 (12-17)
.26
Local progression, n
175
21 (16-28)
186
18 (16-22)
.21
Metastatic progression, n
176
20 (16-25)
17 (14-22)
.24
CRT, chemoradiotherapy; LS-SCLC, limited-scope small-cell lung cancer; TTP, time to progression.
Slide credit: clinicaloptions.com
Faivre-Finn C, et al. ASCO Abstract 8504.

8. Once- vs Twice-Daily Concurrent CRT in LS-SCLC (CONVERT): Toxicity
Comparable toxicities in twice-daily and once-daily arms except for significantly more grade 3-5 neutropenia in twice-daily RT arm
Similar rates of severe esophagitis, severe pneumonitis between treatment arms
Late toxicities mostly grades 0-2
More grade 1/2 esophagitis with once-daily vs twice-daily RT: 16.7% vs 11.7%
No myelitis grade > 1
1 pt with grade 4 pneumonitis in each arm
AE, %
Twice Daily
Once Daily
P Value
(0-2 vs 3-5)
Treatment-related neutropenia
Grade 1/2
Grade 3-5
13.7
74.1
18.1
65.4
.03
Grade 3-5 esophagitis
18.5
19.2
.85
Grade 3-5 pneumonitis
Deaths (from radiation pneumonitis), n
2.0 1
2.4 2
.70
AE, adverse event; CRT, chemoradiotherapy; LS-SCLC, limited-scope small-cell lung cancer; RT, radiotherapy.
Slide credit: clinicaloptions.com
Faivre-Finn C, et al. ASCO Abstract 8504.

9. Once- vs Twice-Daily Concurrent CRT in LS-SCLC (CONVERT): Conclusions
Similar OS with both once-daily and twice-daily concurrent RT
2-yr OS: 56% with twice daily vs 51% with once daily
Median OS: 30 mos with twice daily vs 25 mos with once daily
Better survival than previously reported for both regimens
More RT delivery in twice-daily arm
Similar toxicities, with the exception of significantly more grade 3/4 neutropenia in twice daily arm
No difference in grade 3/4 esophagitis (19% in both arms)
Grade 3/4 radiation pneumonitis rare (2.5% vs 2.2%)
Results support the use of either once-daily or twice-daily RT as SoC for pts with LS-SCLC and good PS
CRT, chemoradiotherapy; LS-SCLC, limited-scope small-cell lung cancer; PS, performance status; RT, radiotherapy; SoC, standard of care.
Slide credit: clinicaloptions.com
Faivre-Finn C, et al. ASCO Abstract 8504.

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