Statistical Analyses

Demographic and baseline characteristics were summarized using descriptive statistics. Categorical variables were summarized with frequency and percentage. Continuous variables were summarized with count, mean, standard deviation, median, minimum, and maximum. Response rate was evaluated as per RECIST 1.1 and presented as frequency and percentage of patients. Survival analysis was performed to measure lifetime or the length of time until the occurrence of an event (death in case of overall survival). Survival data was analyzed using a non-parametric procedure performed on PROC LIFETEST of SAS (Version 9.4) to measure the duration of time until a specified event occurs. OS was calculated and analyzed using Kaplan–Meier method and Log rank test to estimate the survival function from lifetime data after treatment. The AEs were summarized as frequencies and percentages by type of reactions.

RESULTS

Patients Disposition and Demographics


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Data of 91 women with breast cancer, who were treated with NDLS-based chemotherapy, were analyzed. The baseline characteristics of these patients are summarized in Table 1.

Table 1

NDLS was used as a 1-hour infusion in 3-week cycles at a dose of 75 mg/m2 (93.4%, 85/91) or 100 mg/m2 (6.6%, 6/91). NDLS-based regimens were used as first-line therapy in the majority (88.5%) of the patients. Most (n=60, 98.4%) of the patients were administered premedications; dexamethasone was the most common agent. Granulocyte-colony stimulating factor (GCSF) was used in the majority of the patients (97.8%, 90/91) as primary prophylaxis.

NDLS-Based Treatment Regimens

The most common NDLS-based treatment regimens were: neoadjuvant setting, NDLS plus carboplatin plus trastuzumab (TCH, 33.3%, 4/12) and 5-FU plus epirubicin plus cyclophosphamide followed by NDLS (FEC→T, 25%, 3/12); adjuvant setting, NDLS plus cyclophosphamide (TC, 23%, 14/61), TCH and NDLS plus doxorubicin plus cyclophosphamide (TAC) (21.3% each, 13/61), and metastatic setting: NDLS plus carboplatin (44.4%, 8/18) and TCH (33.3%, 6/18).

Efficacy

Of 30 patients who received NDLS for the treatment of breast cancer in metastatic and neoadjuvant settings, efficacy evaluation was available for 29 patients (12/12 in neoadjuvant and 17/18 in metastatic settings). Patients who received NDLS in the adjuvant setting (n=61) were considered for safety and OS analysis. In the neoadjuvant setting, both ORR and DCR were 100% (CR: 50% [6/12], PR: 50% [6/12]), respectively (Figure 1A), whereas in the metastatic setting, ORR was 64.7% (PR: 64.7% [11/17]) and DCR was 70.6% (PR: 64.7% [11/17], SD: 5.6% [1/17]), respectively (Figure 1B).

Figure 1

Overall Survival

Overall, patient survival data was collected from the date of administration of the first dose of NDLS treatment till the last follow-up date (September 30, 2018) for alive patients and date of death for patients who died. Overall, 83.5% (76/91) patients were alive at a median follow-up duration of 21.6 months (range: 2.1–49.9 months). The proportion of patients who were alive was 91.7% (11/12) in the neoadjuvant setting [median follow-up: 21.1 months (range: 2.06–46.8 months)] (Figure 2A), 90.2% (55/61) in the adjuvant setting [median follow-up: 21.6 months (range: 3.5–49.8 months)] (Figure 2B) and 44.4% (10/18) in the metastatic setting [median follow-up: 22.4 months (range: 5.1–36.9 months)] (Figure 2C). The median OS was not reached for patients treated in neoadjuvant and adjuvant settings, whereas it was 30.4 months in metastatic setting.

Figure 2

Safety

The data on AEs were available for 54 patients. Of these, at least one AE was reported in 46 (85.2%) patients. Grade I AEs were reported in 83.3% (45/54) patients, grade II in 42.6% (23/54), grade III in 14.8% (8/54) and grade IV in 5.6% (3/54) patients. Anemia, thrombocytopenia, lymphopenia and neutropenia were the most common hematological AEs, whereas hyperglycemia and alteration in liver function tests were the most common non-hematological AEs reported (Table 2). The AEs of interest with docetaxel such as hypersensitivity reactions, fluid retention, neuropathy and nail disorders, were not reported with the use of NDLS in this study.

Table 2

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