We present a summary of a clinical study that we undertook that yielded very promising results regarding the role of Specific Conjugate Particle (SCP) therapy in the management of advanced or recurrent cervical cancer. Cervical cancer is the second most commonly occurring cancer in women, and it is responsible for 15% of all female malignancies. Metastatic cervical cancer occurs in 15-61% of cases, and available oncology therapies do not offer the prospect of a cure in the majority of patients. Therefore, it is essential that other treatment modalities are developed and evaluated. Given that mandate and the excellent results that we have observed in our other SCPtherapy studies, we undertook a prospective randomized clinical trial.
Entry criteria for the study included that patients must have received one prior systemic chemotherapeutic regimen for the management of advanced, metastatic, or recurrent squamous or non-squamous cell carcinoma of the cervix. Furthermore, patients must not have received prior treatment with a taxane or more than one previous cytotoxic chemotherapy regimen (either with single or combination cytotoxic drug therapy). However, they were permitted to have received one additional non-cytotoxic regimen for the management of recurrent or persistent disease.
Paclitaxel has a broad spectrum of activity against many gynecological malignancies, and oncologists commonly use it in the management of advanced or recurrent cervical cancer. We randomized patients to receive either Specific Conjugate Particle-Paclitaxel (SCP-Paclitaxel) or the conventionally accepted therapy of Nanoparticle, Albumin-Bound Paclitaxel (NAB-Paclitaxel). Patients received either SCP-Paclitaxel or NAB-Paclitaxel 125 mg/m2, intravenously over 30 minutes on days 1, 8 and 15 of a 28-day cycle. No premedication for the prevention of hypersensitivity reaction, nausea or vomiting was required. The maximal body surface area used for dose calculations was 2.0 m2. Patients were allowed to continue on therapy until (1) withdrawal of consent, (2) evidence of disease progression, (3) significant side effects precluding further administration, or (4) inability to tolerate the lowest doses due to toxicity.
We enrolled seventy patients with persistent or recurrent squamous or non-squamous cell carcinoma of the cervix with documented disease progression into the study, and in those we observed one complete response (CR) and 14 Partial Responses (PRs) to therapy. We documented Stable Disease (SD) lasting longer than 16 weeks in 30 subjects (yielding an aggregate overall response rate of 64.3%).
We utilized Cox’s Regression Model of life table analysis to assess outcomes, and we confirmed statistical significance via Kaplan-Meier estimates. Patients receiving SCP-Paclitaxel had a significantly better response to therapy (more CR, PR and SD) than those receiving NAB-Paclitaxel (p<0.05). A total of 8 adverse events occurred in patients receiving NAB-Paclitaxel, whereas there were only three adverse events in patients who received SCP-Paclitaxel. Diarrhea was the most common adverse event in both the groups of patients.
In conclusion, our study has produced very promising results about the role of SCP-Paclitaxel in managing patients who have advanced or recurrent cervical cancer. We found SCP-Paclitaxel to have superior efficacy to NAB-Paclitaxel independent of the patient’s prior therapeutic regime and stage of carcinoma. Furthermore, SCP-Paclitaxel was found to be a comparatively safer treatment regimen with no major side effects and a significantly lower adverse event rate than NAB-Paclitaxel. Given these findings, we plan to seek a 505(b)(2) expedited route to regulatory approval so that SCP therapy can be made available for the management of this otherwise poor prognosis group of patients. You can view a PowerPoint presentation of this study by clicking on this link.
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