Advanced non-small cell lung cancer in elderly patients: A review

Table 1 Results from phase III trials of advanced non-small-cell lung cancer in elderly patients: Non-platinum based chemotherapy

Ref.	Regimen	Age (yr)	No. of patients	RR (%)	MST (mo)
Gridelli[11]	Vinorelbine	70	76	20	6.5
	vs
	Best Supportive Care		78	NA	4.8
Frasci et al[23]	Vinorelbine	70	60	15	4.2
	vs
	Vinorelbine + Gemcitabine		60	22	6.7
Gridelli et al[24]	Vinorelbine or	70	233	18	8.3
	Gemcitabine		233	16	6.5
	vs
	Vinorelbine + Gemcitabine		232	21	6.9
Kudoh et al[22]	Vinorelbine	≥ 70	91	9.9	9.9
	vs
	Docetaxel		88	22.7	14.3
Quoix et al[54]	Vinorelbine or Gemcitabine	≥ 70	226		10.3
	vs
	Carboplatin/paclitaxel		225		6.2
Hainsworth et al[25]	Docetaxel	≥ 65	171	17	5.1
	vs
	Docetaxel/gemcitabine		174	25	5.5

RR: Response rate; MST: Median survival time; NA: Not applicable.

Table 2 Retrospective data analyses of elderly patients enrolled in phase III trials with cisplatin- or carboplatin-based chemotherapy

Ref.	Treatment	Age (yr)	No. of patients	RR	MST (mo)	P value
Nguyen et al[27]	CDDP + GEM	≥ 70	53	15%	7.7	NS
		< 70	207	29%	9.4
Kelly et al[28]	CBDCA + TAX	≥ 70	117	NR	6.9	0.06
	CDDP + VNR	< 70	491	NR	8.6
Langer et al[26]	CDDP + VP-16	≥ 70	86	23.3%	8.5	NS
	CDDP + TAX	< 70	488	21.5%	9.1
Rocha Lima et al[32]	CDDP + VBL	≥ 70	31	16%	5.7	NS
		< 70	222	31%	8.0
Hensing et al[33]	CBDCA + TAX	≥ 70	67	27%	7.1	NS
		< 70	163	20%	7.8
Belani et al[30]	CDDP + TXT	≥ 65	149	NR	12.6	NS
		All ages	408	32%	11.3
	CDDP + VNR	≥ 65	134	NR	9.9	NS
		All ages	404	25%	10.1
	CBDCA + TXT	≥ 65	118	NR	9.0	NS
		All ages	406	24%	9.4
Belani et al[30]	CBDCA + TAXw	≥ 70	70	25.7%	9.2	NR
		< 70	147	28.6%	9.6
	CBDCA + TAX	≥ 70	63	19%	7.7	NR
		< 70	151	19.2%	11.4
Lilenbaum et al[29]	CBDCA + TAX	≥ 70	77	36%	8.0	NS
		< 70	207	30%	8.5

CDDP: Cisplatin; CBDCA: Carboplatin; TAX: Paclitaxel; TXT: Docetaxel; VNR: Vinorelbine; GEM: Gemcitabine; VBL: Vinblastine; VP-16: Etoposide; RR: Response rate; MST: Median survival time; S: Survival; NR: Not reported; NS: Not significant.

Table 3 Phase II trials of cisplatin-based chemotherapy with third-generation agents and modified schedules or attenuated doses of cisplatin

Ref.	Regimen	CDDP dose	Age (yr)	No.of patients	RR	MST (mo)
1Mattioli et al[39]	CDDP + VNR	25 mg/m2, weekly	> 65	36	36%	11
Pereira et al[40]	CDDP + VNR	60-90 mg/m²	> 70	44	50%	7.5
Buffoni et al[41]	CDDP + VNR	30 mg/m², day 1 and 8	≥ 70	30	33%	7.4
Lippe et al[35]	CDDP + GEM	35 mg/m2, weekly	≥ 65	29	48%	10
Berardi et al[36]	CDDP + GEM	35 mg/m2, weekly	≥ 70	48	31.8%	9
Feliu et al[37]	CDDP + GEM	50 mg/m2	≥ 70	46	35%	10.2
Moscetti et al[38]	CDDP + GEM	75 mg/m², day 2	≥ 65	46	45.6%	15
Ohe et al[42]	CDDP + TXT	25 mg/m2, weekly	≥ 75	33	52%	15.8

¹Including 3 unfit patients; CDDP: Cisplatin; VNR: Vinorelbine; GEM: Gemcitabine; TXT: Docetaxel; RR: Response rate; MST: Median survival time; S: Survival.

Table 4 Prospective trials of first line platinum-based chemotherapy in elderly patients affected by advanced non-small-cell lung cancer

Ref.	Regimen	Phase	Age (yr)	No. of patients	Efficacy
Gridelli et al[44]	CDDP + GEM	I/II	≥ 70	159	OS 43.6 wk
					PFS 25.3 wk
					RR 43.5%
	CDDP + VNR				OS 33.1 wk
					PFS 21.1 wk
					RR 36.1%
Abe et al[43]	CDDP + DOC	III	> 70	221	OS 13.3 wk
	vs				OS 17.3 wk
	DOC
Biesma et al[53]	CARBO + GEM	III	≥ 70	181	OS 8.6 mo
	vs				RR 27%
	CARBO + PAC				OS 6.9 mo
					RR 19%
Quoix et al[54]	GEM or VNR	III	≥ 70	451	OS 6.2 mo
	vs				RR 10.9%
	CARBO + PAC				OS 10.3 mo
					RR 29.5%

CDDP: Cisplatin; VNR: Vinorelbine; GEM: Gemcitabine; CARBO: Carboplatin; RR: Response rate; OS: Overall survival.

Table 5 Retrospective analyses of gefitinib in the treatment of unselected elderly patients with advanced non-small-cell lung cancer

Ref.	Previous chemotherapy	Age (yr)	No. of patients	RR (%)	SD (%)	MST (mo)	Toxicity G ≥ 3
Copin et al[58]	Yes (61%)	≥ 70	61	2 (3)	16 (26)	NR	None
	No (39%)
Cavina et al[59]	Yes (64.5%)	≥ 70	31	0 (0)	18 (58)	3.0	G3 skin 10%
	No (35.5%)						G3 diarrhoea 3%
Gridelli et al[60]	Yes (94.5%)	≥ 70	18	0 (0)	2 (11)	4.4	None
	No (5.5%)
Cappuzzo et al[61]	Yes (100%)	≥ 70	40	2 (5)	18 (45)	5.0	G4 diarrhoea 2.5%
Hotta et al[62]	Yes (57%)	≥ 75	92	16 (17)	40 (43)	7.6	G3-4 toxicity 9%
	No (43%)

RR: Response rate; SD: Stable disease; MST: Median survival time; G: Grade; NR: Not reported.

Table 6 Studies with gefitinib (250 mg/d) plus chemotherapy in the treatment of elderly patients (age ≥ 70 years) with advanced non-small-cell lung cancer

Ref.	Treatment	Study phase	No. of patients	RR (%)	SD (%)	MST (mo)	Toxicity G ≥ 3
Stinchcombe et al[63]	TXT 30-36 mg/m², days 1, 8, 15, Q4W	I/II	26	8 (31)	-	6.5	G3-5 toxicity
							42%
Bepler et al[64]	TXT 75 mg/m², day 1, Q3W	II	21	8 (38)	5 (24)	12.4	G3-4 toxicity 28.5%
Scagliotti et al[65]	GEM 1200 mg/m², days 1, 8, Q3W	II Random	35	2 (5.7)	14 (40)	9.1	G3-4 neutropenia 11.4%
	vs
	VNR 30 mg/m², days 1, 8, Q3W		25	0 (0)	11 (44)	12.2	G3-4 neutropenia 72%
							3 toxic deaths

RR: Response rate; SD: Stable disease; MST: Median survival time; G: Grade; TXT: Docetaxel; GEM: Gemcitabine; VNR: Vinorelbine; Q4W: Every 4 wk; Q3W: Every 3 wk; Random: Randomised.

Table 7 Phase II study of single-agent erlotinib in the treatment of advanced non-small-cell lung cancer elderly patients

Ref.	Previous chemotherapy	Age (yr)	No. of patients	RR (%)	SD (%)	MST (mo)	Toxicity G ≥ 3
Jackman et al[67]	No (100%)	≥ 70	58	6 (10.9)	30 (54.5)	10.5	G ≥ 3 toxicity 30%

RR: Response rate; SD: Stable disease; MST: Median survival time; G: Grade.