8058

Prospective observational cohort study of second-line chemotherapy administration after first-line
platinum-based chemotherapy for patients with advanced NSCLC in Japan (SAPPHIRE study)
Kiyotaka Yoh1, Yasushi Goto2, Yoichi Naito3, Kazuma Kishi4, Yasuo Ohashi5, Hideo Kunitoh6
1 Thoracic Oncology Division, National Cancer Center Hospital East; 2 Department of Respiratory Medicine, Graduate School of Medicine, University of Tokyo; 3 Department of Hematology and Medical Oncology, National Cancer Center Hospital East;
4 Department of Respiratory Medicine, Respiratory Center, Toranomon Hospital; 5 Department of Biostatistics, School of Public Health, University of Tokyo; 6 Department of Respiratory Medicine, Mitsui Memorial Hospital, JapanBACKGROUNDRESULTS

Chemotherapy for advanced NSCLC First-line platinum-based chemotherapy (first-line CT) is standard ofcare.
 Second-line chemotherapy (second-line CT) is recommended forpatients who have experienced disease progression after first-line CT.
 However, not all patients could receive appropriate second-line CT.

 A total of 865 eligible patients with advanced NSCLC provided patient characteristics and details of first-line CT(Table 1 and Figure 1).
 At this data cut off of patients who were followed up for at least 6 months, 797 patients were assessable forresponse and the response rate was 35% (276/797) (Figure 2).

Maintenance therapy in the treatment of advanced NSCLC Maintenance therapy after first-line CT is reported to be beneficial.
 However, its impact on overall survival appears to be marginal or
negligible, if those without maintenance receive active second-line CT,
which is initiated at disease progression.

OBJECTIVE
 To investigate the proportion of patients with NSCLC who had
progression during observation after CR/PR/SD of first-line CT and
further received appropriate second-line CT To elucidate the reasons and factors which hinder patients fromreceiving second-line CT

METHODS
Study design
 Cohort study
Primary endpoint Proportion of patients who received second-line CT for progression
during observation after CR/PR/SD of first-line CT
Patient inclusion
 Patients with advanced or recurrent NSCLC who were initiated on
first-line CT Between April 2010 and September 2011 from 30 institutions in Japan Without history of other active malignancy
Data collection
 Patient characteristics including age, sex, PS (ECOG), smoking
status, comorbidities (diabetes mellitus, cardiac disease, interstitiallung disease), body mass index, histological subtype, EGFR/ALK
status, CBC/chemistry at registration
 Details of first-, second-, third-line CT and maintenance therapy;
including regimen, response Reason for administration or omitting second-line CT Survival
Data cutoff
 This interim report describes from patients with at least 6 months offollow up at April 2012.

Figure 2. CONSORT diagram for this interim analysis

Table 1. Patient characteristics
Characteristics

No. of patients(n = 865)

Sexmale/female

628/237

Age
median (range)
70 or more

65 (24-86)
250

Histology
Adeno
Squamous
NSCLC (NOS)
Others

%
73/27

29602
174
73
16

70
20
8
2

PS (ECOG)
0/1/2/3-4
unknown

343/449/65/7
1

40/52/7/1

Smoking
never/everunknown

173/687
520/79Comorbidities
none
any

654
211

76
24

EGFR status
mutantwild
unknown

87515
2631060
30

Table 2. Summary of second-line treatment

Table 4. Association between baseline characteristics
and administration of second-line CT (n = 508)

Second-linetreatment

No. of patients(n = 508)%

BSC (none)

132

26

Docetaxel
Pemetrexed
Erlotinib
S-1
Gefitinib
Any single agent
Any combination CT

152
68
30
1816
1874

30
13643414

Table 3. The reasons for not receiving second-line CT
Reasons
Declined PS
Patient refusal
Death of any cause
Loss of follow-up and othersn = 132 (%)
79 (60)28 (21)6 (5)19 (14)

Second line CT(yes/no)
Characteristicsn(%)

All of patients

376/132(74/26)PSex

malefemale

272/103
104/29(73/27)(78/22)0.21

Age< 65> 65

175/45201/87(80/20)(70/30)

0.01

PS

01-4

179/31
197/101(85/15) < 0.0001(66/34)

Smoking

never
ever

81/15
295/117(84/16)(72/28)0.01

Comorbidities

none
any

288/9088/42(76/24)(68/32)

0.06

Platinumregimen

CDDP
other

144/40232/92(78/22)(72/28)

0.11

CONCLUSIONS At this data cut off, 194 patients received maintenancetherapy after first-line CT and were excluded from primarystudy population.

Figure 1. Summary of first-line platinum-based chemotherapy (n = 865)

Squamous (n = 174)

 Preliminary results of this large observational study in Japan indicated that around 30% of patients missed an
opportunity to receive appropriate second-line CT despite observation after first-line CT.
 Final analysis will be performed using data that all patients were followed up for at least 1.5 years.
 Our goal is to elucidate the selection criteria of patients that may benefit the most from maintenance therapy,
not second-line CT which is initiated at disease progression.
Acknowledgement

CDDP, cisplatin
CBDCA, carboplatin
PEM, pemetrexed
PTX, paclitaxel
DOC, docetaxel
GEM, gemcitabine
VNR, vinorelbine
BEV, bevacizumab
NEDA, nedaplatin
IRI, irinotecanNon-squamous (n = 691)

 Among the 508 patients who had progression after CR/PR/SD, 376 patients (74%) could receive second-line CT
at disease progression and 132 patients (26%) not receive second-line CT (Table 2).
 Declined PS was the most common reason for hindering second-line CT (Table 3).
 Advanced age, declined PS and smoking history were correlated with hindrance to second-line CT in univariateanalysis (Table 4).

This study was funded by Comprehensive Support Project for Oncology Research (CSPOR) of Public Health Research
Foundation. We would like to thank patients, their families, and following institutions;
Hokkaido University Hospital, KKR Sapporo Medical Center, Iwate Prefectural Central Hospital, Tohoku University Hospital,
University of Tsukuba, Ibaraki Prefectural Central Hospital, Tochigi Cancer Center, Gunma Prefectural Cancer Center,Saitama Medical University International Medical Center, Saitama Cancer Center, Tokyo Metropolitan Cancer and Infectious
Diseases Center Komagome Hospital, The Cancer Institute Hospital Of JFCR, Japanese Red Cross Medical Center, Kitasato
University Hospital, Kanagawa Cardiovascular and Respiratory Center, Fujisawa City Hospital, Shinshu University Hospital,
Nagoya University Graduate School Of Medicine, Okayama University Hospital, Hiroshima Prefectural Hospital, Kurume
University School of Medicine, Nagasaki University Hospital, Mitsui Memorial Hospital, University of Tokyo Hospital,National Cancer Center Hospital East, Toranomon Hospital, Nishigunma National Hospital, NTT Medical Center Tokyo,Teikyo University School of Medicine, National Center for Global Health and Medicine
Presented at the 49th American Society of Clinical Oncology Annual Meeting, Chicago, IL, USA, May 31-June 4, 2013